Original Article
Long-Term Effects of Indomethacin Prophylaxis in Extremely-Low-Birth-Weight Infants
N Engl J Med 2001; 344:1966-1972June 28, 2001
- Abstract
Background
The prophylactic administration of indomethacin reduces the frequency of patent ductus arteriosus and severe intraventricular hemorrhage in very-low-birth-weight infants (those with birth weights below 1500 g). Whether prophylaxis with indomethacin confers any long-term benefits that outweigh the risks of drug-induced reductions in renal, intestinal, and cerebral blood flow is not known.
Methods
Soon after they were born, we randomly assigned 1202 infants with birth weights of 500 to 999 g (extremely low birth weight) to receive either indomethacin (0.1 mg per kilogram of body weight) or placebo intravenously once daily for three days. The primary outcome was a composite of death, cerebral palsy, cognitive delay, deafness, and blindness at a corrected age of 18 months. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly within the same time frame. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, ultrasonographic evidence of intracranial abnormalities, necrotizing enterocolitis, and retinopathy.
Results
Of the 574 infants with data on the primary outcome who were assigned to prophylaxis with indomethacin, 271 (47 percent) died or survived with impairments, as compared with 261 of the 569 infants (46 percent) assigned to placebo (odds ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4; P=0.61). Indomethacin reduced the incidence of patent ductus arteriosus (24 percent, vs. 50 percent in the placebo group; odds ratio, 0.3; P<0.001) and of severe periventricular and intraventricular hemorrhage (9 percent, vs. 13 percent in the placebo group; odds ratio, 0.6; P=0.02). No other outcomes were altered by the prophylactic administration of indomethacin.
Conclusions
In extremely-low-birth-weight infants, prophylaxis with indomethacin does not improve the rate of survival without neurosensory impairment at 18 months, despite the fact that it reduces the frequency of patent ductus arteriosus and severe periventricular and intraventricular hemorrhage.
Media in This Article
Figure 1
Numbers of Infants Who Were Screened and Randomly Assigned to the Indomethacin and Placebo Groups, and Numbers for Whom Follow-up Data Were Available.Figure 2
Kaplan–Meier Estimates of the Cumulative Risk of Death in the Indomethacin and Placebo Groups.Article Activity
- Article
The prophylactic administration of indomethacin reduces the incidence of patent ductus arteriosus and severe intraventricular hemorrhage in very-low-birth-weight infants (those with birth weights below 1500 g).1 Our current understanding of the mechanisms by which indomethacin prevents intraventricular hemorrhage is speculative2 and indicates that a decrease in cerebral perfusion may be involved.3,4 Although such a decrease may provide protection against intraventricular hemorrhage,4 it may also increase the risk of brain ischemia.3 Knowledge about the effects of indomethacin prophylaxis on neurologic development is therefore crucial, but few data are available on its longer-term motor, sensory, and cognitive effects.1
We undertook this study to determine whether the prophylactic administration of indomethacin improves survival without neurosensory impairment in extremely-low-birth-weight infants (those with birth weights below 1000 g). A secondary goal was to obtain additional information about the effects of indomethacin on the incidence of patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, necrotizing enterocolitis, intracranial abnormalities, and retinopathy.
Methods
Study Infants
Infants with birth weights ranging from 500 to 999 g were considered for enrollment when they were two hours old. The criteria for exclusion are listed in Figure 1Figure 1
Numbers of Infants Who Were Screened and Randomly Assigned to the Indomethacin and Placebo Groups, and Numbers for Whom Follow-up Data Were Available.. A history, a physical examination, and a platelet count were the only screening tests prescribed by the protocol. The research-ethics boards of all 32 participating clinical centers approved the protocol, and written informed consent was obtained from a parent or guardian of each infant. Investigational-new-drug applications were filed with Health Canada and the U.S. Food and Drug Administration because indomethacin is not approved for prophylactic administration in preterm infants in either country. Clinical-trial-notification applications were filed in Australia. The recruitment of infants began at different times in different centers, between January 1996 and October 1997. Enrollment was completed in March 1998.Randomization
A computer-generated randomization scheme was used to assign the infants (in random blocks of two or four) to treatment groups in a 1:1 ratio. Randomization was stratified according to birth weight (500 to 749 g vs. 750 to 999 g) and according to study center. Each study pharmacist received a binder containing the sequence of treatment-group assignments for each birth-weight stratum from a statistician at the coordinating center who was not otherwise involved in the trial. At each study center, access to the binder was restricted to selected pharmacy personnel.
Intervention
The infants received either indomethacin, 0.1 mg per kilogram of body weight (Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa.), or an equivalent volume of normal saline. Three doses were given at 24-hour intervals. Each dose was infused intravenously over a period of 20 minutes. Since even a small volume of reconstituted indomethacin has a slightly yellow tinge, all syringes were partially masked with yellow tape.
Primary Outcome
The primary outcome was death before a corrected age of 18 months or documentation in survivors of one or more of the following: cerebral palsy, cognitive delay, hearing loss requiring amplification, and bilateral blindness. Cerebral palsy was diagnosed if the child had nonprogressive motor impairment characterized by abnormal muscle tone and a decreased range or control of movements. Cognitive delay was defined as a Mental Development Index score of less than 70 (2 SD below the mean of 100) on the Bayley Scales of Infant Development II.5 A score between 85 and 114 is classified as normal, and scores lower than 70 suggest that cognitive development is markedly delayed.5 The score was assumed to be less than 70 if the child could not be tested because of severe developmental delay. Audiometry was performed to determine the presence or absence of hearing loss. A central adjudication committee that was unaware of the group assignments reviewed the results of audiologic tests for all infants with potential deafness whose hearing had not been amplified. Blindness was defined as a corrected visual acuity of less than 20/200. A follow-up evaluation was targeted for a corrected age of 18 months, but the protocol allowed a window of 18 to 21 months (12 to 21 months for audiologic testing). Efforts to conduct assessments continued beyond a corrected age of 21 months in an attempt to ensure the completeness of the results. Home visits or assessments in facilities not participating in the study were permitted when necessary.
Documentation of the composite primary outcome required confirmation that the infant had died or had survived with any one of the four types of impairment, and documentation of the absence of the primary outcome required confirmation that the infant had survived without any impairment. Since a single missing component of the follow-up assessment would result in a designation of “missing” for the primary outcome, the steering committee developed detailed a priori criteria to determine what constituted adequate evidence of the presence or absence of each component of the primary outcome. These criteria required an in-person assessment by an appropriate health professional and the completion of the psychometric assessment during or after the permissible time window. In cases in which it was difficult to obtain audiometric test results, deafness requiring amplification of hearing was assumed to be absent if there was no indication of hearing loss during the clinical examination and the Bayley test. This assumption was made in the cases of 27 children.
Secondary Outcomes
Hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly (a head circumference below the 3rd percentile for a reference population of normal children6) were secondary long-term outcomes. While the infants were hospitalized in the neonatal intensive care unit, various short-term outcomes were assessed. Patent ductus arteriosus was diagnosed by echocardiography and Doppler flow studies, which were requested only when there was a clinical suspicion of the condition. Left-to-right ductal shunting had to be confirmed by echocardiography with Doppler flow before drug or surgical therapy to close the duct was undertaken.7 Pulmonary hemorrhage was diagnosed if a blood-tinged tracheal aspirate was obtained. Chronic lung disease was defined by the need for supplemental oxygen at 36 weeks of postmenstrual age.8
Cranial ultrasonography was recommended between the 5th and 8th days of life, between the 21st and 28th days, and between 34 and 36 weeks of postmenstrual age if the infant was still hospitalized in the study center at that time. The scans were read locally, and copies of the written reports were sent to the coordinating center. Hemorrhages were analyzed separately so that we could compare our results with those of previous investigators. Hemorrhages of grade 3 or 4 were considered severe.9 Several types of lesions were considered as a group because they all indicate probable damage to the cerebral white matter10; these included echodense intraparenchymal lesions, periventricular leukomalacia, porencephalic cysts, and ventriculomegaly with or without intraventricular hemorrhage. Necrotizing enterocolitis was diagnosed during surgery, at autopsy, or by a finding of pneumatosis intestinalis, hepatobiliary gas, or free intraperitoneal air on radiography. Retinopathy was diagnosed according to the international classification.11,12
Statistical Analysis
All primary and secondary outcomes were dichotomous. Since randomization was stratified according to birth weight and study center, the analyses of outcomes were adjusted for these two factors with the use of a logistic-regression model13 that included terms for treatment, birth-weight stratum, center (smaller centers were combined), and interactions between birth weight and center when appropriate. The regression coefficient associated with treatment in the fitted model yielded a point estimate and confidence interval for the treatment effect expressed as an odds ratio. The quotient of the estimated coefficient and its standard error was used as a z-test statistic for the null hypothesis of no treatment effect. Cumulative mortality was estimated with the Kaplan–Meier13 method. All P values are two-sided and have not been adjusted for multiple testing.
An external safety monitoring committee reviewed the study data every four to six months during the enrollment phase. With the exception of this monitoring committee and the local study pharmacists, no one involved in the study or in the care and follow-up of the infants was aware of the treatment-group assignments.
Results
Study Infants and Intervention
The numbers of infants who were eligible for the study, the numbers assigned to receive indomethacin or placebo, and the numbers for whom follow-up data were available are shown in Figure 1. A total of 1202 infants were enrolled — 505 in Canada; 384 in Australia, New Zealand, and Hong Kong; and 313 in the United States. The base-line characteristics of the infants in the two groups and of their mothers were similar (Table 1Table 1
Base-Line Characteristics of the Infants and Their Mothers.). A total of 92 percent of the infants were given at least two doses of either indomethacin or placebo, and the infants in each group received an identical mean (±SD) total dose of study drug that was equivalent to 0.27±0.07 mg of indomethacin per kilogram. The number of doses received, the reasons for withholding one or more doses, and the age of the infants at the time the first dose was administered are shown in Table 2Table 2
Number of Doses of Study Drug Administered, Reasons for Withholding Doses, and Age at First Dose..Primary Outcome at a Corrected Age of 18 Months
Adequate data for an analysis of the composite primary outcome were available for 1143 of the infants who were enrolled in the study (95 percent). Indomethacin prophylaxis did not improve the rate of survival without neurosensory impairment (Table 3Table 3
Primary Outcome of Death or Neurosensory Impairment.). Adjustments for prespecified and prognostically important base-line characteristics (presence or absence of antenatal administration of glucocorticoids, mother's educational level, infant's gestational age, and presence or absence of a multiple birth) yielded the same odds ratio. There was also little evidence that indomethacin prophylaxis altered the rates of any of the individual components of the primary outcome (Figure 2Figure 2Kaplan–Meier Estimates of the Cumulative Risk of Death in the Indomethacin and Placebo Groups. and Table 3). The mean (±SD) Mental Development Index score was 83±18 in the indomethacin group and 84±18 in the placebo group. The median age at follow-up was 18.5 months (interquartile range, 18.1 to 19.5) in the indomethacin group and 18.4 months (18.1 to 19.3) in the placebo group.A single predefined subgroup analysis showed a consistent lack of an effect of indomethacin treatment in each birth-weight stratum. A total of 152 of the 240 infants in the indomethacin group with birth weights between 500 and 749 g (63 percent) died or survived with one or more impairments, as compared with 146 of the 241 infants in the placebo group in that birth-weight stratum (61 percent). The corresponding rates for infants with birth weights between 750 and 999 g were 119 of the 334 infants in the indomethacin group (36 percent), and 115 of the 328 infants in the placebo group (35 percent).
Secondary Outcomes
Among the survivors, the incidence rates of hydrocephalus requiring the placement of a shunt, seizure disorder, and microcephaly were not affected by the administration of indomethacin (Table 4Table 4
Long-Term and Short-Term Secondary Outcomes in the Infants in the Indomethacin and Placebo Groups.). Indomethacin prophylaxis reduced the incidence of patent ductus arteriosus. Consistent with this reduction, the need for drug or surgical therapy to close the duct was also reduced in the infants in the indomethacin group (Table 4).Although the rates of periventricular and intraventricular hemorrhage were identical in the two treatment groups, the risk of grade 3 or grade 4 hemorrhages was lower in the indomethacin group (Table 4). However, the incidence of any type of lesion indicative of injury to the cerebral white matter was similar in the two groups, as was the incidence of all other secondary short-term outcomes (Table 4).
Discussion
We found that the use of indomethacin prophylaxis to reduce the incidence of patent ductus arteriosus and of severe periventricular and intraventricular hemorrhage in extremely-low-birth-weight infants did not improve the rate of survival without neurosensory impairment at a corrected age of 18 months. Also, indomethacin prophylaxis did not reduce the incidence of any of the individual events included in the composite primary outcome in this trial. Moreover, it is unlikely that indomethacin prophylaxis will be beneficial in the smallest infants, since we found no differential treatment effect in an analysis stratified according to birth weight.
It is unlikely that we missed a clinically important long-term effect of indomethacin. A post hoc calculation confirmed that we would have been able to detect a 20 percent reduction in risk, had it existed, with a power of 90 percent, and we think that our estimate of the long-term effects of indomethacin prophylaxis is unbiased. The investigators and anyone involved in the care or follow-up of the infants in the study remained unaware of the treatment-group assignments throughout the trial, and ascertainment of the primary outcome toward the end of the second year of life was nearly complete. This is important because preterm infants who are followed up with ease may not have the same outcomes as those who are followed up with difficulty.15 In this trial, only 13 children were entirely lost to follow-up, and the analysis of the primary outcome was based on results from 95 percent of all the infants who had been assigned to a treatment group.
Information about the long-term effects of indomethacin prophylaxis has been derived primarily from a trial by Ment et al.16 In that study, indomethacin prophylaxis also failed to reduce the rates of cerebral palsy, deafness, and blindness.17,18 However, Ment et al. reported a favorable effect of indomethacin prophylaxis on cognitive function in a subgroup of children who spoke English as their only language at 4.5 years of age.18 Our trial, however, was designed to test different hypotheses from those of the trial by Ment et al., and we had different criteria for enrollment, different primary end points, and different rates of follow-up. For example, we did not exclude infants with preexisting periventricular or intraventricular hemorrhage. Our relatively unrestrictive criteria for eligibility should increase the generalizability of our results.19
We administered the Bayley Scales of Infant Development II at a corrected age of 18 months and found that more than one quarter of all the surviving infants had moderate-to-severe cognitive delays, defined as a Mental Development Index score of less than 70. Although this finding is alarming, it is consistent with those of two recent studies that used the same scales to measure the cognitive function of extremely-low-birth-weight infants at a corrected age of 18 months and of 30 months, respectively.20,21 The validity of the Mental Development Index score at this age as a predictor of later intellectual functioning remains to be determined. However, we doubt that extended follow-up will uncover substantial benefits of prophylaxis with indomethacin.
In our trial, indomethacin did not reduce the incidence of lesions that may signify white-matter injury, although it did reduce the incidence of severe periventricular and intraventricular hemorrhage. Why, then, did this reduction not translate into a better long-term outcome? Severe hemorrhage was associated with a poor outcome, but the incidence of severe hemorrhage was quite low, and the absolute reduction in incidence associated with indomethacin prophylaxis was small (4 percentage points). This reduction in the incidence of severe hemorrhage would account for an absolute reduction of only 1.6 percent in the primary outcome.
On the basis of the previously documented short-term benefits, many clinicians have adopted a policy of administering indomethacin prophylaxis in very-low-birth-weight infants, although others have remained skeptical of this approach.2 What are the implications of our findings for the care of very preterm infants? Indomethacin prophylaxis reduces the need for medical and surgical closure of the ductus arteriosus. Approximately 20 infants must receive indomethacin prophylaxis to avert one operation.22 Our results suggest that closure of the ductus with the prophylactic administration of indomethacin can be achieved without serious adverse effects on outcomes such as necrotizing enterocolitis or retinopathy. However, indomethacin prophylaxis should not be prescribed with the expectation that the chances of survival without neurosensory impairment will be improved. We must look elsewhere in our quest to reduce the high rates of adverse outcomes in extremely-low-birth-weight infants.
Supported by a grant from the Medical Research Council of Canada (MT-13288) and by grants from the National Institute of Child Health and Human Development to participating centers in the United States (U10 HD21364, U10 HD27851, U10 HD21373, U10 HD27881, M01 RR 00997, U10 HD27880, M01 RR 00070, U10 HD21385, U10 HD27904, and U10 HD34216). Indocid P.D.A. was donated by Merck Frosst and Merck.
Source Information
From the Departments of Pediatrics (B.S., S.S.) and Clinical Epidemiology and Biostatistics (B.S., A.O., R.S.R.), McMaster University, Hamilton, Ont., Canada; the Royal Women's Hospital, Melbourne, Australia (P.D.); the Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada (D.M.); the Departments of Pediatrics, Obstetrics and Gynecology, and Health Administration, University of Toronto, Toronto (A.O.); the Department of Pediatrics, University of British Columbia, Vancouver, Canada (A.S.); the Department of Pediatrics, Dalhousie University, Halifax, N.S., Canada (M.V.); and the Neonatal Research Network, National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W.).
Address reprint requests to Dr. Schmidt at the Department of Pediatrics, McMaster University, HSC 3N11E, 1200 Main St. W., Hamilton, ON, L8N 3Z5, Canada, or at schmidt@mcmaster.ca.
Other members of the study group are listed in the Appendix.
Appendix
In addition to the authors, who formed the Steering Committee, the following institutions and persons participated in the trial: Canada: British Columbia Children's Hospital, Vancouver — M. Whitfield, F. Germain, J. Tomlinson; Royal Alexandra Hospital, Edmonton, Alta. — A. Peliowski, P. Etches, B. Young; Glenrose Rehabilitation Hospital, Edmonton, Alta. — C. Robertson; Foothills Hospital and Alberta Children's Hospital, Calgary — D. McMillan, R. Sauve, L. Bourcier, H. Christianson; Royal University Hospital, Saskatoon, Sask. — K. Sankaran, B. Andreychuk; Health Sciences Centre, Winnipeg, Man. — M. Seshia, O. Casiro, V. Debooy, V. Cook; St. Boniface Hospital, Winnipeg, Man. — C. Cronin, N. Granke; The Salvation Army Grace Hospital, Windsor, Ont. — C. Nwaesei, L. St. Aubin; St. Joseph's Health Centre, London, Ont. — D. Reid, D. Lee, C. Kenyon, L. Whitty, J. Farrell; Hamilton Health Sciences, Hamilton, Ont. — P. Gillie, J. Dix, B. Zhang; Women's College Hospital, Toronto — E. Asztalos, L. Wiley; Hospital for Sick Children, Toronto — A. James; Kingston General Hospital, Kingston, Ont. — K. Young Tai, M. Clarke; IWK Grace Health Centre, Halifax, N.S. — S. Stone. Australia: King Edward Memorial Hospital for Women, Perth — R. Kohan, N. French, H. Benninger; Women's and Children's Hospital, Adelaide — C. Barnett, R. Haslam, J. Ramsay; Royal Women's Hospital, Melbourne — L. Doyle, B. Faber, K. Callanan; Mercy Hospital for Women, Melbourne — S. Fraser; Westmead Hospital, Westmead — K. Lui, M. Rochefort, E. McAvoy; Royal Women's Hospital, Brisbane — P. Colditz, M. Pritchard; Mater Mothers' Hospital, Brisbane — P. Steer, D. Tudehope, V. Flenady, J. Hegarty. New Zealand: National Women's Hospital and Middlemore Hospital, Auckland — L. Mildenhall, W. Smith, L. McCarthy. Hong Kong: Prince of Wales Hospital, Shatin — T. Fok. United States: Stanford University Medical Center, Palo Alto, Calif. — D. Stevenson, B. Fleisher, B. Ball; University of New Mexico School of Medicine, Albuquerque — L. Papile, G. Laadt, C. Backstrom; University of Texas Southwestern Medical Center at Dallas — J. Tyson, S. Broyles, S. Madison; University of Alabama, Birmingham — W. Carlo, K. Nelson, M. Collins, S. Johnson; Children's Hospital of Michigan, Detroit — S. Shankaran, V. Delaney-Black, G. Muran, D. Driscoll; Emory University, Atlanta — B. Stoll, N. Simon, E. Hale; Case Western Reserve University, Cleveland — A. Fanaroff, D. Wilson, M. Hack, N. Newman; University of Miami, Miami — C. Bauer, A. Worth, W. Griffin; Brown University, Providence, R.I. — W. Oh, B. Vohr, A. Hensman. External Safety Monitoring Committee: M. Gent, W. Fraser, M. Perlman. Bayley Scales of Infant Development II Certification: R. Adkins. Audiology Central Adjudication Committee: L. Elden, C. Robertson, B. Vohr. Consultant Pharmacist: S. Gray. Coordinating and Methods Center: K. Thorpe (junior biostatistician); N. LaPierre (trial coordinator).
- References
References
1
Fowlie PW. Intravenous indomethacin for preventing mortality and morbidity in very low birth weight infants (Cochrane review). In: The Cochrane library, issue 4. Oxford, England: Update Software, 2000 (software).
2
Bada HS . Routine indomethacin prophylaxis: has the time come? Pediatrics 1996;98:784-785
Web of Science | Medline3
Edwards AD ,Wyatt JS ,Richardson C , et al. Effects of indomethacin on cerebral haemodynamics in very preterm infants. Lancet 1990;335:1491-1495
CrossRef | Web of Science | Medline4
Yanowitz TD ,Yao AC ,Werner JC ,Pettigrew KD ,Oh W ,Stonestreet BS . Effects of prophylactic low-dose indomethacin on hemodynamics in very low birth weight infants. J Pediatr 1998;132:28-34
CrossRef | Web of Science | Medline5
Bayley N. Manual for the Bayley Scales of Infant Development. 2nd ed. San Antonio, Tex.: Psychological Corporation, 1993.
6
CDC growth charts 2000. Atlanta: Centers for Disease Control and Prevention, 2000. (See http://www.cdc.gov/growthcharts.) (See NAPS document no. 05596 for 4 pages, c/o Microfiche Publications, 248 Hempstead Tpke., West Hempstead, NY 11552.)
7
Davis P ,Turner-Gomes S ,Cunningham K ,Way C ,Roberts R ,Schmidt B . Precision and accuracy of clinical and radiological signs in premature infants at risk of patent ductus arteriosus. Arch Pediatr Adolesc Med 1995;149:1136-1141
Web of Science | Medline8
Shennan AT ,Dunn MS ,Ohlsson A ,Lennox K ,Hoskins EM . Abnormal pulmonary outcomes in premature infants: prediction from oxygen requirement in the neonatal period. Pediatrics 1988;82:527-532
Web of Science | Medline9
Papile LA ,Burstein J ,Burstein R ,Koffler H . Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr 1978;92:529-534
CrossRef | Web of Science | Medline10
Pinto-Martin JA ,Riolo S ,Cnaan A ,Holzman C ,Susser MW ,Paneth N . Cranial ultrasound prediction of disabling and nondisabling cerebral palsy at age two in a low birth weight population. Pediatrics 1995;95:249-254
Web of Science | Medline11
An international classification of retinopathy of prematurity. Pediatrics 1984;74:127-133
Web of Science | Medline12
The International Committee for the Classification of the Late Stages of Retinopathy of Prematurity
Web of Science | Medline13
Pagano M, Gauvreau K. Principles of biostatistics. Belmont, Calif.: Duxbury Press, 1993.
14
Arbuckle TE ,Sherman GJ . An analysis of birth weight by gestational age in Canada. CMAJ 1989;140:157-60, 165
Web of Science | Medline15
Tin W ,Fritz S ,Wariyar U ,Hey E . Outcome of very preterm birth: children reviewed with ease at 2 years differ from those followed up with difficulty. Arch Dis Child Fetal Neonatal Ed 1998;79:F83-F87
CrossRef | Web of Science | Medline16
Ment LR ,Oh W ,Ehrenkranz RA , et al. Low-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial. Pediatrics 1994;93:543-550
Web of Science | Medline17
Ment LR ,Vohr B ,Oh W , et al. Neurodevelopmental outcome at 36 months' corrected age of preterm infants in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial. Pediatrics 1996;98:714-718
Web of Science | Medline18
Ment LR ,Vohr B ,Allan W , et al. Outcome of children in the indomethacin intraventricular hemorrhage prevention trial. Pediatrics 2000;105:485-491
CrossRef | Web of Science | Medline19
Yusuf S ,Held P ,Teo KK ,Toretsky ER . Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria. Stat Med 1990;9:73-86
CrossRef | Web of Science | Medline20
Vohr BR ,Wright LL ,Dusick AM , et al. Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994. Pediatrics 2000;105:1216-1226
CrossRef | Web of Science | Medline21
Wood NS ,Marlow N ,Costeloe K ,Gibson AT ,Wilkinson AR . Neurologic and developmental disability after extremely preterm birth. N Engl J Med 2000;343:378-384
Full Text | Web of Science | Medline22
Laupacis A ,Sackett DL ,Roberts RS . An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988;318:1728-1733
Full Text | Web of Science | Medline
- Citing Articles (161)
Citing Articles
1
R S Garner, C Miller, D J Burchfield. (2012) Prophylactic indomethacin infusion increases fractional cerebral oxygen extraction in ELBW neonates. Journal of Perinatology
CrossRef2
Ronald I. Clyman. 2012. Patent Ductus Arteriosus in the Preterm Infant. , 751-761.
CrossRef3
Eric C. Eichenwald. 2012. Care of the Extremely Low-Birthweight Infant. , 390-404.
CrossRef4
Sonia L. Bonifacio, Fernando Gonzalez, Donna M. Ferriero. 2012. Central Nervous System Injury and Neuroprotection. , 869-891.
CrossRef5
Valerie Y. Chock, Chandra Ramamoorthy, Krisa P. Van Meurs. (2012) Cerebral Autoregulation in Neonates with a Hemodynamically Significant Patent Ductus Arteriosus. The Journal of Pediatrics
CrossRef6
Dan L. Ellsbury, Robert Ursprung. (2012) A Quality Improvement Approach to Optimizing Medication Use in the Neonatal Intensive Care Unit. Clinics in Perinatology
CrossRef7
Palmer G. Johnston, Maria Gillam-Krakauer, M. Paige Fuller, Jeff Reese. (2012) Evidence-Based Use of Indomethacin and Ibuprofen in the Neonatal Intensive Care Unit. Clinics in Perinatology
CrossRef8
Ilene R.S. Sosenko, M. Florencia Fajardo, Nelson Claure, Eduardo Bancalari. (2012) Timing of Patent Ductus Arteriosus Treatment and Respiratory Outcome in Premature Infants: A Double-Blind Randomized Controlled Trial. The Journal of Pediatrics
CrossRef9
Olli Leppänen, Matias Ekstrand, Jan Hinrich Bräsen, Max Levin. (2011) Bioluminescence imaging of energy depletion in vascular pathology: patent ductus arteriosus and atherosclerosis. Journal of Biophotonicsn/a-n/a
CrossRef10
Matthew V. Covey, Dean Loporchio, Krista D. Buono, Steven W. Levison. (2011) Opposite effect of inflammation on subventricular zone versus hippocampal precursors in brain injury. Annals of Neurology 70:4, 616-626
CrossRef11
Joanne Lagatta, Bree Andrews, Leslie Caldarelli, Michael Schreiber, Susan Plesha-Troyke, William Meadow. (2011) Early Neonatal Intensive Care Unit Therapy Improves Predictive Power for the Outcomes of Ventilated Extremely Low Birth Weight Infants. The Journal of Pediatrics 159:3, 384-391.e1
CrossRef12
Pracha Nuntnarumit, Prapaiporn Chongkongkiat, Anant Khositseth. (2011) N-terminal-pro-brain natriuretic peptide: a guide for early targeted indomethacin therapy for patent ductus arteriosus in preterm Infants. Acta Paediatrica 100:9, 1217-1221
CrossRef13
Eric Herlenius. (2011) An inflammatory pathway to apnea and autonomic dysregulation. Respiratory Physiology & Neurobiology 178:3, 449-457
CrossRef14
Gülcan Türker, Gamze Özsoy, Ayla Günlemez, Ayşe S. Gökalp, Ayşe E. Arisoy, Zelal Bircan. (2011) Acute renal failure SNAPPE and mortality. Pediatrics International 53:4, 483-488
CrossRef15
Amuchou S. Soraisham, Reg Sauve, Nalini Singhal. (2011) Indomethacin Tocolysis and Neurodevelopmental Outcome. The Indian Journal of Pediatrics 78:8, 946-952
CrossRef16
Arne Ohlsson, Sachin S Shah, Arne Ohlsson. 2011. Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef17
Jasim Anabrees, Khalid AlFaleh, Jasim Anabrees. 2011. Fluid restriction and prophylactic indomethacin versus prophylactic indomethacin alone for prevention of morbidity and mortality in extremely low birth weight infants. .
CrossRef18
Lex W. Doyle, Peter G. Davis, Barbara Schmidt, Peter J. Anderson. (2011) Cognitive outcome at 24months is more predictive than at 18months for IQ at 8–9years in extremely low birth weight children. Early Human Development
CrossRef19
K AlFaleh. (2011) Indomethacin prophylaxis revisited: changing practice and supportive evidence. Acta Paediatrica 100:5, 641-646
CrossRef20
Vineet Bhandari, Catalin S. Buhimschi, Christina S. Han, Sarah Y. Lee, Christian M. Pettker, Katherine H. Campbell, Antonette T. Dulay, Emily A. Oliver, Erika F. Werner, Irina A. Buhimschi. (2011) Cord blood erythropoietin and interleukin-6 for prediction of intraventricular hemorrhage in the preterm neonate. Journal of Maternal-Fetal and Neonatal Medicine 24:5, 673-679
CrossRef21
David A. Kaufman, Amy L. Cuff, Julia B. Wamstad, Robert Boyle, Matthew J. Gurka, Leigh B. Grossman, Peter Patrick. (2011) Fluconazole Prophylaxis in Extremely Low Birth Weight Infants and Neurodevelopmental Outcomes and Quality of Life at 8 to 10 Years of Age. The Journal of Pediatrics 158:5, 759-765.e1
CrossRef22
W E Benitz. (2011) Learning to live with patency of the ductus arteriosus in preterm infants. Journal of Perinatology 31, S42-S48
CrossRef23
A. Whitelaw. (2011) Core Concepts: Intraventricular Hemorrhage. NeoReviews 12:2, e94-e101
CrossRef24
Peter J. Davis, Adrian Bosenberg, Andrew Davidson, Nathalia Jimenez, Evan Kharasch, Anne M. Lynn, Stevan P. Tofovic, Susan Woelfel. 2011. Pharmacology of Pediatric Anesthesia. , 179-261.
CrossRef25
Valerie Y. Chock, Chandra Ramamoorthy, Krisa P. Van Meurs. (2011) Cerebral Oxygenation during Different Treatment Strategies for a Patent Ductus Arteriosus. Neonatology 100:3, 233-240
CrossRef26
Y Katayama, H Minami, M Enomoto, T Takano, S Hayashi, Y K Lee. (2011) Antenatal magnesium sulfate and the postnatal response of the ductus arteriosus to indomethacin in extremely preterm neonates. Journal of Perinatology 31:1, 21-24
CrossRef27
Mun Soo Yeo, KyungVin Choi, Hyun Ju Lee, Hyun Kyung Park, Chang Ryul Kim, In Joon Seol. (2011) Effect of Prophylactic Ibuprofen in Preterm Infants Less than 1,250 g in Birth Weight. Journal of the Korean Society of Neonatology 18:2, 234
CrossRef28
Masahiro Tsuji, Naoya Aoo, Kazuhiro Harada, Yuya Sakamoto, Yoshiharu Akitake, Keiichi Irie, Kenichi Mishima, Tomoaki Ikeda, Michihiro Fujiwara. (2010) Sex differences in the benefits of rehabilitative training during adolescence following neonatal hypoxia–ischemia in rats. Experimental Neurology 226:2, 285-292
CrossRef29
A Flisberg, I Kjellmer, J Löfhede, N Löfgren, M Rosa-Zurera, K Lindecrantz, M Thordstein. (2010) Does indomethacin for closure of patent ductus arteriosus affect cerebral function?. Acta Paediatrica 99:10, 1493-1497
CrossRef30
S Noori. (2010) Patent ductus arteriosus in the preterm infant: to treat or not to treat?. Journal of Perinatology 30, S31-S37
CrossRef31
A Janvier, J L Martinez, K Barrington, J Lavoie. (2010) Anesthetic technique and postoperative outcome in preterm infants undergoing PDA closure. Journal of Perinatology 30:10, 677-682
CrossRef32
NAHID WALEH, RYAN HODNICK, NAMI JHAVERI, SUZANNE McCONAGHY, JOHN DAGLE, STEVEN SEIDNER, DONALD McCURNIN, JEFFREY C. MURRAY, ROBIN OHLS, RONALD I. CLYMAN. (2010) Patterns of Gene Expression in the Ductus Arteriosus Are Related to Environmental and Genetic Risk Factors for Persistent Ductus Patency. Pediatric Research 68:4, 292-297
CrossRef33
MICHELLE LOELIGER, AMY SHIELDS, DONALD McCURNIN, RONALD I. CLYMAN, BRADLEY YODER, TERRIE E. INDER, SANDRA M. REES. (2010) Ibuprofen Treatment for Closure of Patent Ductus Arteriosus Is Not Associated With Increased Risk of Neuropathology. Pediatric Research 68:4, 298-302
CrossRef34
Véronique Gournay. (2010) The ductus arteriosus: Physiology, regulation, and functional and congenital anomalies. Archives of Cardiovascular Diseases
CrossRef35
R. Mosalli, B. Paes. (2010) Patent Ductus Arteriosus: Optimal Fluid Requirements in Preterm Infants. NeoReviews 11:9, e495-e502
CrossRef36
Nami Jhaveri, Anita Moon-Grady, Ronald I. Clyman. (2010) Early Surgical Ligation Versus a Conservative Approach for Management of Patent Ductus Arteriosus That Fails to Close after Indomethacin Treatment. The Journal of Pediatrics 157:3, 381-387.e1
CrossRef37
F G Ramos, C R Rosenfeld, L Roy, J Koch, C Ramaciotti. (2010) Echocardiographic predictors of symptomatic patent ductus arteriosus in extremely-low-birth-weight preterm neonates. Journal of Perinatology 30:8, 535-539
CrossRef38
Peter W Fowlie, Peter G Davis, William McGuire, Peter W Fowlie. 2010. Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants. .
CrossRef39
Seiji Yoshimoto, Hitomi Sakai, Masaaki Ueda, Mayumi Yoshikata, Masami Mizobuchi, Hideto Nakao. (2010) Prophylactic indomethacin in extremely premature infants between 23 and 24 weeks gestation. Pediatrics International 52:3, 374-377
CrossRef40
Arne Ohlsson, Rajneesh Walia, Sachin S Shah, Arne Ohlsson. 2010. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef41
W E Benitz. (2010) Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis?. Journal of Perinatology 30:4, 241-252
CrossRef42
Peter W Fowlie, Peter G Davis. (2010) Cochrane Review: Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants. Evidence-Based Child Health: A Cochrane Review Journal 5:1, 416-471
CrossRef43
Anna Ells, Duane L Guernsey, Karin Wallace, Binyou Zheng, Michael Vincer, Alexander Allen, April Ingram, Orlando DaSilva, Lee Siebert, Thomas Sheidow, Jill Beis, Johane M. Robitaille. (2010) Severe retinopathy of prematurity associated with FZD4 mutations. Ophthalmic Genetics 31:1, 37-43
CrossRef44
Roger F. Soll. (2010) Evaluating the Medical Evidence for Quality Improvement. Clinics in Perinatology 37:1, 11-28
CrossRef45
Roger F. Soll. (2010) The Cochrane Neonatal Review Group: who we are and what we have done. Evidence-Based Child Health: A Cochrane Review Journal 5:1, 3-10
CrossRef46
Ju Young Lee, Han Suk Kim, Euiseok Jung, Eun Sun Kim, Gyu Hong Shim, Hyun Joo Lee, Jin A Lee, Chang Won Choi, Ee-Kyung Kim, Beyong Il Kim, Jung-Hwan Choi. (2010) Risk Factors for Periventricular-Intraventricular Hemorrhage in Premature Infants. Journal of Korean Medical Science 25:3, 418
CrossRef47
Ran D. Goldman, Abraham Spierer, Alexander Zhurkovsky, Jacob Kwint, Monica Schwarcz, Guy J. Ben Simon. (2010) Retinopathy of Prematurity in Very Low Birth Weight Infants and the Potential Protective Role of Indomethacin. Ophthalmic Surgery, Lasers, and Imaging 41:1, 41-47
CrossRef48
Win Tin, Thomas E. Wiswell. (2009) Drug therapies in bronchopulmonary dysplasia: debunking the myths. Seminars in Fetal and Neonatal Medicine 14:6, 383-390
CrossRef49
Haim Bassan. (2009) Intracranial Hemorrhage in the Preterm Infant: Understanding It, Preventing It. Clinics in Perinatology 36:4, 737-762
CrossRef50
Shahab Noori, Istvan Seri. (2009) Treatment of the Patent Ductus Arteriosus: When, How, and for How Long?. The Journal of Pediatrics 155:6, 774-776
CrossRef51
Matthew M. Laughon, P. Brian Smith, Carl Bose. (2009) Prevention of bronchopulmonary dysplasia. Seminars in Fetal and Neonatal Medicine 14:6, 374-382
CrossRef52
Jeffrey M. Perlman. (2009) The Relationship Between Systemic Hemodynamic Perturbations and Periventricular-Intraventricular Hemorrhage—A Historical Perspective. Seminars in Pediatric Neurology 16:4, 191-199
CrossRef53
Matthew Derrick, Alexander Drobyshevsky, Xinhai Ji, Lina Chen, Yirong Yang, Haitao Ji, Richard B. Silverman, Sidhartha Tan. (2009) Hypoxia–ischemia causes persistent movement deficits in a perinatal rabbit model of cerebral palsy: assessed by a new swim test. International Journal of Developmental Neuroscience 27:6, 549-557
CrossRef54
CA Nankervis, EM Martin, ML Crane, KS Samson, SE Welty, LD Nelin. (2009) Implementation of a multidisciplinary guideline-driven approach to the care of the extremely premature infant improved hospital outcomes. Acta Paediatrica
CrossRef55
Adam B Hoellering, Lucy Cooke. (2009) The management of patent ductus arteriosus in Australia and New Zealand. Journal of Paediatrics and Child Health 45:4, 204-209
CrossRef56
Arpitha Chiruvolu, Mambarath A. Jaleel. (2009) Therapeutic management of patent ductus arteriosus. Early Human Development 85:3, 151-155
CrossRef57
Jasim Anabrees, Khalid M AlFaleh, Jasim Anabrees. 2009. Fluid restriction and prophylactic indomethacin versus prophylactic indomethacin alone for prevention of morbidity and mortality in extremely low birth weight infants. .
CrossRef58
Nadeen Edmondson, Alan Bocking, Geoffrey Machin, Rose Rizek, Carole Watson, Sarah Keating. (2009) The Prevalence of Chronic Deciduitis in Cases of Preterm Labor without Clinical Chorioamnionitis. Pediatric and Developmental Pathology 12:1, 16-21
CrossRef59
Heather J. McCrea, Laura R. Ment. (2008) The Diagnosis, Management, and Postnatal Prevention of Intraventricular Hemorrhage in the Preterm Neonate. Clinics in Perinatology 35:4, 777-792
CrossRef60
Andrew J. Davidson, Mary Ellen McCann, Neil S. Morton, Paul S. Myles. (2008) Anesthesia and Outcome after Neonatal Surgery. Anesthesiology 109:6, 941-944
CrossRef61
Yigit S. Guner, Nikunj Chokshi, Mikael Petrosyan, Jeffrey S. Upperman, Henri R. Ford, Tracy C. Grikscheit. (2008) Necrotizing enterocolitis — bench to bedside: novel and emerging strategies. Seminars in Pediatric Surgery 17:4, 255-265
CrossRef62
Patricia Maddalena, Sharyn Gibbins. (2008) Cerebellar Hemorrhage in Extremely Low Birth Weight Infants: Incidence, Risk Factors, and Impact on Long-Term Outcomes. Neonatal Network: The Journal of Neonatal Nursing 27:6, 387-396
CrossRef63
J. Gien. (2008) Controversies in the Management of Patent Ductus Arteriosus. NeoReviews 9:10, e477-e482
CrossRef64
Vinita B Pai, Arpi Sakadjian, Teresa D Puthoff. (2008) Ibuprofen Lysine for the Prevention and Treatment of Patent Ductus Arteriosus. Pharmacotherapy 28:9, 1162-1182
CrossRef65
Madhavi Sangem, Sumita Asthana, Sanjiv Amin. (2008) Multiple Courses of Indomethacin and Neonatal Outcomes in Premature Infants. Pediatric Cardiology 29:5, 878-884
CrossRef66
B E Stephens, B R Vohr. (2008) Fluid regimens and the risk of patent ductus arteriosus in extremely low birth weight infants. Journal of Perinatology 28:9, 653-653
CrossRef67
R M McAdams. (2008) Fluid regimens and the risk of patent ductus arteriosus in extremely low birth weight infants. Journal of Perinatology 28:9, 652-653
CrossRef68
Carol Scott, Ruth Wittmann-Price, Gayle Thear. (2008) Keeping a Watchful Eye on Retinopathy of Prematurity. Neonatal Network: The Journal of Neonatal Nursing 27:5, 355-357
CrossRef69
CHRISTOPH CZERNIK, JULIA LEMMER, BORIS METZE, PETRA S. KOEHNE, CHRISTIAN MUELLER, MICHAEL OBLADEN. (2008) B-Type Natriuretic Peptide to Predict Ductus Intervention in Infants <28 Weeks. Pediatric Research 64:3, 286-290
CrossRef70
Vibhuti S Shah, Prakesh S Shah. (2008) Promising new strategies for bronchopulmonary dysplasia in infants. Pediatric Health 2:3, 315-331
CrossRef71
Chuan-Zhong Yang, Jiun Lee. (2008) Factors affecting successful closure of hemodynamically significant patent ductus arteriosus with indomethacin in extremely low birth weight infants. World Journal of Pediatrics 4:2, 91-96
CrossRef72
K C Sekar, K E Corff. (2008) Treatment of patent ductus arteriosus: indomethacin or ibuprofen?. Journal of Perinatology 28, S60-S62
CrossRef73
Eichenwald, Eric C., Stark, Ann R., . (2008) Management and Outcomes of Very Low Birth Weight. New England Journal of Medicine 358:16, 1700-1711
Full Text74
M. Jeeva Sankar, Ramesh Agarwal, Ashok K. Deorari, Vinod K. Paul. (2008) Chronic lung disease in newborns. The Indian Journal of Pediatrics 75:4, 369-376
CrossRef75
Andrew J. A. Holland. (2008) Comment on Kubota et al.: Focal intestinal perforation in extremely-low-birth-weight neonates: etiological consideration from histological findings. Pediatric Surgery International 24:3, 387-387
CrossRef76
Nicholas D. Embleton, Rowena Yates. (2008) Probiotics and other preventative strategies for necrotising enterocolitis. Seminars in Fetal and Neonatal Medicine 13:1, 35-43
CrossRef77
Win Tin, Thomas E. Wiswell. (2008) Adjunctive therapies in chronic lung disease: Examining the evidence. Seminars in Fetal and Neonatal Medicine 13:1, 44-52
CrossRef78
Arne Ohlsson, Rajneesh Walia, Sachin S Shah, Arne Ohlsson. 2008. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef79
Manoj N Malviya, Arne Ohlsson, Sachin S Shah, Manoj N Malviya. 2008. Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants. .
CrossRef80
Rafat Mosalli, Khalid AlFaleh, Rafat Mosalli. 2008. Prophylactic surgical ligation of patent ductus arteriosus for prevention of mortality and morbidity in extremely low birth weight infants. .
CrossRef81
Hyun Ju Lee, Gyu Hong Sim, Kyung Eun Jung, Jin A Lee, Chang Won Choi, Ee Kyung Kim, Han Suk Kim, Beyong Il Kim, Jung-Hwan Choi. (2008) Delayed closure effect in preterm infants with patent ductus arteriosus. Korean Journal of Pediatrics 51:10, 1065
CrossRef82
Vincent C. Smith. 2008. Intraventricular Hemorrhage and Posthemorrhagic Hydrocephalus. , 143-148.
CrossRef83
W F Liu, S Laudert, B Perkins, E MacMillan-York, S Martin, S Graven. (2007) The development of potentially better practices to support the neurodevelopment of infants in the NICU. Journal of Perinatology 27, S48-S74
CrossRef84
Nancy Chorne, Priya Jegatheesan, Emil Lin, Robert Shi, Ronald I. Clyman. (2007) Risk Factors for Persistent Ductus Arteriosus Patency during Indomethacin Treatment. The Journal of Pediatrics 151:6, 629-634
CrossRef85
Saleh A. Al-Amro, Turki M. Al-Kharfi, Abdulla A. Thabit, Saleh M. Al-Mofada. (2007) Risk Factors for Acute Retinopathy of Prematurity. Comprehensive Therapy 33:2, 73-77
CrossRef86
P V Gordon, J R Swanson, J T Attridge, R Clark. (2007) Emerging trends in acquired neonatal intestinal disease: is it time to abandon Bell's criteria?. Journal of Perinatology 27:11, 661-671
CrossRef87
Andrew Whitelaw, David Odd, Andrew Whitelaw. 2007. Postnatal phenobarbital for the prevention of intraventricular hemorrhage in preterm infants. .
CrossRef88
Saleh A. Al-Amro, Turki M. Al-Kharfi, Abdulla A. Thabit, Saleh M. Al-Mofada. (2007) Risk Factors for Acute Retinopathy of Prematurity. Annals of Ophthalmology 39:2, 107-111
CrossRef89
Saroj Saigal, Peter Rosenbaum. (2007) What matters in the long term: Reflections on the context of adult outcomes versus detailed measures in childhood. Seminars in Fetal and Neonatal Medicine 12:5, 415-422
CrossRef90
Stéphane Marret, Lex W. Doyle, Caroline A. Crowther, Philippa Middleton. (2007) Antenatal magnesium sulphate neuroprotection in the preterm infant. Seminars in Fetal and Neonatal Medicine 12:4, 311-317
CrossRef91
David Sweet, Giulio Bevilacqua, Virgilio Carnielli, Gorm Greisen, Richard Plavka, Ola Didrik Saugstad, Umberto Simeoni, Christian P. Speer, Adolf Valls-i-Soler, Henry Halliday. (2007) European consensus guidelines on the management of neonatal respiratory distress syndrome. Journal of Perinatal Medicine 35:3, 175-186
CrossRef92
S. B. Amin, C. Handley, O. Carter-Pokras. (2007) Indomethacin Use for the Management of Patent Ductus Arteriosus in Preterms: A Web-Based Survey of Practice Attitudes Among Neonatal Fellowship Program Directors in the United States. Pediatric Cardiology 28:3, 193-200
CrossRef93
Carmen M. Herrera, James R Holberton, Peter G Davis, Carmen M. Herrera. 2007. Prolonged versus short course of indomethacin for the treatment of patent ductus arteriosus in preterm infants. .
CrossRef94
Fatih Mehmet Mutlu, Serdar Ümit Sarici. (2007) Retinopathy of prematurity: incidence and risk factors. Expert Review of Ophthalmology 2:2, 267-274
CrossRef95
Nandkishor S. Kabra, Barbara Schmidt, Robin S. Roberts, Lex W. Doyle, Luann Papile, Avroy Fanaroff. (2007) Neurosensory Impairment after Surgical Closure of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants: Results from the Trial of Indomethacin Prophylaxis in Preterms. The Journal of Pediatrics 150:3, 229-234.e1
CrossRef96
L Cordero, C A Nankervis, D DeLooze, P J Giannone. (2007) Indomethacin prophylaxis or expectant treatment of patent ductus arteriosus in extremely low birth weight infants?. Journal of Perinatology 27:3, 158-163
CrossRef97
M Laughon, C Bose, R Clark. (2007) Treatment strategies to prevent or close a patent ductus arteriosus in preterm infants and outcomes. Journal of Perinatology 27:3, 164-170
CrossRef98
Ronald I. Clyman, Nancy Chorne. (2007) Patent Ductus Arteriosus: Evidence for and against Treatment. The Journal of Pediatrics 150:3, 216-219
CrossRef99
Martin Kluckow, Istvan Seri, Nick Evans. (2007) Functional Echocardiography: An Emerging Clinical Tool for the Neonatologist. The Journal of Pediatrics 150:2, 125-130
CrossRef100
L Cordero, C A Nankervis, D Gardner, P J Giannone. (2007) The effects of indomethacin tocolysis on the postnatal response of the ductus arteriosus to indomethacin in extremely low birth weight infants. Journal of Perinatology 27:1, 22-27
CrossRef101
Ronald I. Clyman, Shampa Saha, Alan Jobe, William Oh. (2007) Indomethacin Prophylaxis for Preterm Infants: The Impact of 2 Multicentered Randomized Controlled Trials on Clinical Practice. The Journal of Pediatrics 150:1, 46-50.e2
CrossRef102
AnnMarie DiBiasie. (2006) Evidence-Based Review of Retinopathy of Prematurity Prevention in VLBW and ELBW Infants. Neonatal Network: The Journal of Neonatal Nursing 25:6, 393-403
CrossRef103
R Mosalli, K AlFaleh, Rafat Mosalli. 2006. Prophylactic surgical ligation of patent ductus arteriosus for prevention of mortality and morbidity in extremely low birth weight infants. .
CrossRef104
Kristi Watterberg. (2006) Anti-inflammatory therapy in the neonatal intensive care unit: Present and future. Seminars in Fetal and Neonatal Medicine 11:5, 378-384
CrossRef105
SS Shah, A Ohlsson. (2006) Cochrane review: Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. Evidence-Based Child Health: A Cochrane Review Journal 1:3, 773-807
CrossRef106
A Ohlsson, R Walia, S Shah. (2006) Cochrane review: Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. Evidence-Based Child Health: A Cochrane Review Journal 1:3, 812-845
CrossRef107
Bernard Thébaud. (2006) Commentary on ‘Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants’ and ‘Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants’. Evidence-Based Child Health: A Cochrane Review Journal 1:3, 850-853
CrossRef108
Anne R. Synnes, Ying C. MacNab, Zhenguo Qiu, Arne Ohlsson, Paul Gustafson, Charmaine B. Dean, Shoo K. Lee. (2006) Neonatal Intensive Care Unit Characteristics Affect the Incidence of Severe Intraventricular Hemorrhage. Medical Care 44:8, 754-759
CrossRef109
Patricia R. Chess, Carl T. D’Angio, Gloria S. Pryhuber, William M. Maniscalco. (2006) Pathogenesis of Bronchopulmonary Dysplasia. Seminars in Perinatology 30:4, 171-178
CrossRef110
L Paquette, P Friedlich, R Ramanathan, I Seri. (2006) Concurrent use of indomethacin and dexamethasone increases the risk of spontaneous intestinal perforation in very low birth weight neonates. Journal of Perinatology 26:8, 486-492
CrossRef111
E R Hermes-DeSantis, R I Clyman. (2006) Patent ductus arteriosus: pathophysiology and management. Journal of Perinatology 26, S14-S18
CrossRef112
Marta Thakkar, Michael O'Shea. (2006) The role of neonatal networks. Seminars in Fetal and Neonatal Medicine 11:2, 105-110
CrossRef113
Lex W. Doyle. (2006) The burden of illness in perinatal and neonatal care: The epidemiologist's role. Seminars in Fetal and Neonatal Medicine 11:2, 69-72
CrossRef114
Katherine Telford, Lorraine Waters, Harish Vyas, Bradley N Manktelow, Elizabeth S Draper, Neil Marlow. (2006) Outcome after neonatal continuous negative-pressure ventilation: follow-up assessment. The Lancet 367:9516, 1080-1085
CrossRef115
J T Attridge, R Clark, M W Walker, P V Gordon. (2006) New insights into spontaneous intestinal perforation using a national data set: (2) two populations of patients with perforations. Journal of Perinatology 26:3, 185-188
CrossRef116
John A.F. Zupancic, Douglas K. Richardson, Bernie J. O'Brien, Catherine G. Cronin, Barbara Schmidt, Robin Roberts, Milton C. Weinstein. (2006) Retrospective economic evaluation of a controlled trial of indomethacin prophylaxis for patent ductus arteriosus in premature infants. Early Human Development 82:2, 97-103
CrossRef117
J T Attridge, R Clark, M W Walker, P V Gordon. (2006) New insights into spontaneous intestinal perforation using a national data set: (1) SIP is associated with early indomethacin exposure. Journal of Perinatology 26:2, 93-99
CrossRef118
Arne Ohlsson, Sachin S Shah, Arne Ohlsson. 2006. Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef119
Bo Lyun Lee, Su Jin Kim, Soo Hyun Koo, Ga Won Jeon, Yun Sil Chang, Won Soon Park. (2006) Effect of prophylactic indomethacin in extremely low birth weight infants. Korean Journal of Pediatrics 49:9, 959
CrossRef120
Ronald I. Clyman. (2006) Mechanisms Regulating the Ductus Arteriosus. Biology of the Neonate 89:4, 330-335
CrossRef121
Karel Allegaert, Christine Vanhole, Jan Hoon, Jean Pierre Guignard, Dick Tibboel, Hugo Devlieger, Bart Overmeire. (2005) Nonselective cyclo-oxygenase inhibitors and glomerular filtration rate in preterm neonates. Pediatric Nephrology 20:11, 1557-1561
CrossRef122
Sanjeev Sanjeev, Michael Pettersen, Jorge Lua, Ronald Thomas, Seetha Shankaran, Thomas L'Ecuyer. (2005) Role of Plasma B-Type Natriuretic Peptide in Screening for Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates. Journal of Perinatology 25:11, 709-713
CrossRef123
A Ohlsson, R Walia, S Shah, Arne Ohlsson. 2005. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef124
Mark S. Scher, John Turnbull, Kenneth Loparo, Mark W. Johnson. (2005) Automated State Analyses: Proposed Applications to Neonatal Neurointensive Care. Journal of Clinical Neurophysiology 22:4, 256-270
CrossRef125
Karel Allegaert, Veerle Cossey, Anne Debeer, Jean Paul Langhendries, Bart Overmeire, Jan Hoon, Hugo Devlieger. (2005) The impact of ibuprofen on renal clearance in preterm infants is independent of the gestational age. Pediatric Nephrology 20:6, 740-743
CrossRef126
Bart Van Overmeire, Sylvain Chemtob. (2005) The pharmacologic closure of the patent ductus arteriosus. Seminars in Fetal and Neonatal Medicine 10:2, 177-184
CrossRef127
Ronald L. Thomas, Graham C. Parker, Bart Overmeire, Jacob V. Aranda. (2005) A meta-analysis of ibuprofen versus indomethacin for closure of patent ductus arteriosus. European Journal of Pediatrics 164:3, 135-140
CrossRef128
Shaul Dollberg, Ayala Lusky, Brian Reichman. (2005) Patent Ductus Arteriosus, Indomethacin and Necrotizing Enterocolitis in Very Low Birth Weight Infants: A Population-Based Study. Journal of Pediatric Gastroenterology and Nutrition 40:2, 184-188
CrossRef129
NAHID WALEH, STEVEN SEIDNER, DONALD MCCURNIN, BRADLEY YODER, BAO MEI LIU, CHRISTINE ROMAN, FRAN??OISE MAURAY, RONALD I. CLYMAN. (2005) The Role of Monocyte-Derived Cells and Inflammation in Baboon Ductus Arteriosus Remodeling. Pediatric Research 57:2, 254-262
CrossRef130
Ronald I. Clyman. 2005. Patent Ductus Arteriosus in the Premature Infant. , 816-826.
CrossRef131
Ashima Madan, Shannon E.G. Hamrick, Donna M. Ferriero. 2005. Central Nervous System Injury and Neuroprotection. , 965-992.
CrossRef132
V Gournay, JC Roze, A Kuster, P Daoud, G Cambonie, JM Hascoet, C Chamboux, T Blanc, C Fichtner, C Savagner, JB Gouyon, V Flurin, G Thiriez. (2004) Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. The Lancet 364:9449, 1939-1944
CrossRef133
Bart Van Overmeire, Karel Allegaert, Alexandra Casaer, Christian Debauche, Wim Decaluwé, Ann Jespers, Joost Weyler, Inge Harrewijn, Jean-Paul Langhendries. (2004) Prophylactic ibuprofen in premature infants: a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet 364:9449, 1945-1949
CrossRef134
Heike Rabe, Graham J Reynolds, Jose Luis Diaz-Rosello, Heike Rabe. 2004. Early versus delayed umbilical cord clamping in preterm infants. .
CrossRef135
Cindy McEvoy, Susan Bowling, Kathleen Williamson, Pam McGaw, Manuel Durand. (2004) Randomized, double-blinded trial of low-dose dexamethasone: II. Functional residual capacity and pulmonary outcome in very low birth weight infants at risk for bronchopulmonary dysplasia. Pediatric Pulmonology 38:1, 55-63
CrossRef136
Matthew M Laughon, Michael A Simmons, Carl L Bose. (2004) Patency of the ductus arteriosus in the premature infant: is it pathologic? Should it be treated?. Current Opinion in Pediatrics 16:2, 146-151
CrossRef137
Carl T D???Angio, William M Maniscalco. (2004) Bronchopulmonary Dysplasia in Preterm Infants. Pediatric Drugs 6:5, 303-330
CrossRef138
Pen-Hua Su, Jia-Yuh Chen, Chi-Ming Su, Tzu-Ching Huang, Hong-Shen Lee. (2003) Comparison of ibuprofen and indomethacin therapy for patent ductus arteriosus in preterm infants. Pediatrics International 45:6, 665-670
CrossRef139
J LOUDON, K GROOM, P BENNETT. (2003) Prostaglandin inhibitors in preterm labour. Best Practice & Research Clinical Obstetrics & Gynaecology 17:5, 731-744
CrossRef140
A Leonhardt, HW Seyberth. (2003) Do we need another NSAID instead of indomethacin for treatment of ductus arteriosus in preterm infants?. Acta Paediatrica 92:9, 996-999
CrossRef141
Betty R Vohr, Michael O’Shea, Linda L Wright. (2003) Longitudinal multicenter follow-up of high-risk infants: why, who, when, and what to assess. Seminars in Perinatology 27:4, 333-342
CrossRef142
Richard A. Ehrenkranz, Linda L. Wright. (2003) NICHD neonatal research network: contributions and future challenges. Seminars in Perinatology 27:4, 264-280
CrossRef143
Marya Strand, Alan H Jobe. (2003) The multiple negative randomized controlled trials in perinatology—why?. Seminars in Perinatology 27:4, 343-350
CrossRef144
Barbara J Stoll, Nellie Hansen. (2003) Infections in VLBW infants: studies from the NICHD neonatal research network. Seminars in Perinatology 27:4, 293-301
CrossRef145
M Malviya, A Ohlsson, S Shah, Manoj Malviya. 2003. Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants. .
CrossRef146
SS Shah, A Ohlsson, Sachin Shah. 2003. Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. .
CrossRef147
Sharyn Gibbins, Bonnie Stevens, Elizabeth Asztalos. (2003) Assessment and management of acute pain in high-risk neonates. Expert Opinion on Pharmacotherapy 4:4, 475-483
CrossRef148
K. Allegaert, S. Vanhaesebrouck, G. Naulaers, C. Vanhole, M. Gewillig, H. Devlieger, W. Proesmans. (2003) Prostaglandines en de neonatale nier: klinische relevantie van een fysiologisch evenwicht. Tijdschrift voor kindergeneeskunde 71:6, 7-10
CrossRef149
Lucy Cooke, Peter A Steer, Paul G Woodgate, Lucy Cooke. 2003. Indomethacin for asymptomatic patent ductus arteriosus in preterm infants. .
CrossRef150
David K Stevenson, Amnon Goldworth. (2002) Ethical considerations in neuroimaging and its impact on decision-making for neonates. Brain and Cognition 50:3, 449-454
CrossRef151
Wolfgang Pumberger, Markus Mayr, Christine Kohlhauser, Manfred Weninger. (2002) Spontaneous localized intestinal perforation in very-low-birth-weight infants:. Journal of the American College of Surgeons 195:6, 796-803
CrossRef152
Barbara Schmidt, Linda L Wright, Peter Davis, Alfonso Solimano, Robin S Roberts. (2002) Ibuprofen prophylaxis in preterm neonates. The Lancet 360:9331, 492
CrossRef153
Peter W Fowlie, Peter G Davis, Peter W Fowlie. 2002. Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants. .
CrossRef154
Edmund Hey. (2002) Clinical trials: when to start and when to stop. The Lancet 359:9316, 1449
CrossRef155
JoAnn Harrold, Barbara Schmidt. (2002) Evidence-based neonatology: making a difference beyond discharge from the neonatal nursery. Current Opinion in Pediatrics 14:2, 165-169
CrossRef156
V Gournay, C Savagner, G Thiriez, A Kuster, J-C Rozé. (2002) Pulmonary hypertension after ibuprofen prophylaxis in very preterm infants. The Lancet 359:9316, 1486-1488
CrossRef157
Arne Ohlsson. (2002) No indications of increased quiet sleep in infants who receive care based on the Newborn Individualized Care and Assessment Program (NIDCAP). Acta Paediatrica 91:3, 262-263
CrossRef158
Marilee C. Allen. (2002) Preterm outcomes research: A critical component of neonatal intensive care. Mental Retardation and Developmental Disabilities Research Reviews 8:4, 221-233
CrossRef159
Michael E. Msall, Michelle R. Tremont. (2002) Measuring functional outcomes after prematurity: Developmental impact of very low birth weight and extremely low birth weight status on childhood disability. Mental Retardation and Developmental Disabilities Research Reviews 8:4, 258-272
CrossRef160
Elizabeth V Asztalos, Jon F. R Barrett, Maralyn Lacy, Maureen Luther. (2001) Evaluating 2 Year Outcome in Twins ? 30 Weeks Gestation at Birth: A Regional Perinatal Unit's Experience. Twin Research and Human Genetics 4:6, 431-438
CrossRef161
C Herrera, J Holberton, P Davis, Carmen Herrera. 2001. Prolonged versus short course of indomethacin for the treatment of patent ductus arteriosus in preterm infants. .
CrossRef
