Correspondence
Viability of Infants Born at 22 to 25 Weeks' Gestation
N Engl J Med 1994; 330:1234-1236April 28, 1994
- Article
To the Editor:
A methodologic problem besets the evaluation of the appropriate health care for very premature infants -- namely, the unaccounted-for heterogeneity in obstetrical and neonatal care received by these fetuses and infants. Unless this factor is taken into consideration, differences in outcome attributed to gestational age could, in fact, be due to gestational-age-dependent differences in the intensiveness of care.
Dr. Allen and her colleagues (Nov. 25 issue)1 describe gestational-age-determined differences in the intensiveness of obstetrical care offered to fetuses in their cohort. They report that obstetricians tried to avoid performing cesarean sections at 22 to 24 weeks' gestation. Do the authors think this helps explain the large difference in the number of deaths between infants born at 22 to 24 weeks and those born at 25 weeks? Was the condition of the younger fetuses who survived to birth more compromised than that of the older fetuses who were eligible for cesarean section for fetal distress? Was the intensiveness of neonatal resuscitation related to gestational age? Did any of the infants born at 22 to 24 weeks receive both intensive obstetrical and neonatal care? If not, how can we use these results to argue that intensive care is ineffective or inappropriate for this age group?
1 ReferencesMary Lynne Reuss, M.D., M.P.H.
Columbia University, New York, NY 100321
Allen MC ,Donohue PK ,Dusman AE . The limit of viability -- neonatal outcome of infants born at 22 to 25 weeks' gestation. N Engl J Med 1993;329:1597-1601
Full Text | Web of Science | Medline
To the Editor:
The report by Allen et al. of their experience with 142 infants delivered at 22 to 25 weeks' gestation raises important questions about the limits of viability and the appropriate level of medical intervention for infants born at these gestational ages. We were surprised by the authors' statement that they studied all infants born at their institution between May 26, 1988, “when routine prophylactic administration of calf-lung surfactant extract (Infasurf) was begun,” and September 3, 1991. Infasurf is an investigational drug, and during the latter part of the study period an approved surfactant was available. Furthermore, the prophylactic administration of surfactant was experimental during this period. The authors do not include information about parental consent or about what the parents were told about alternative approaches to treatment.
There is little evidence that surfactant therapy benefits infants born at 22 to 24 weeks' gestation. In the randomized, placebo-controlled trial by Stevenson et al.1 of infants with a birth weight of 500 to 699 g who were treated with surfactant, there was no improvement in overall survival, although there was a decrease in deaths attributable to respiratory distress syndrome and an increase in pulmonary hemorrhage.
In the present study, the results suggest that the authors' treatment of infants born at 23 weeks' gestation may have lengthened their survival by only a few weeks. Figure 1 of Allen et al. shows that survival decreased progressively from about 30 percent at the time of admission to the neonatal intensive care unit to 15 percent one month later (a mortality of 50 percent). The trend was similar for infants born at 24 weeks' gestation. Given these results, the question of what information the parents and those paying for the health care of these tiny infants were given about their participation in a clinical trial is central to the issues of resource use and the choice of an appropriate level of therapy.
Although survival for six months may be considered to represent a short-term success of neonatal intensive care, better measures of success are the proportion of infants who function in the normal range at two years of age and the proportion with normal school performance2. Unfortunately, it is not uncommon for large amounts of resources to be expended on neonatal intensive care for vulnerable infants who continue to require special services from a health care system ill equipped and insufficiently funded to provide for their long-term support.
Dr. Allen and colleagues suggest that their findings should be used to help parents and physicians choose the best treatment strategies for very immature infants. We agree that providing timely and relevant data on outcomes is an essential part of counseling prospective parents. We would like to know how the authors currently use their results to counsel the parents of infants delivered at 22 to 24 weeks' gestation about neonatal resuscitation, surfactant administration, the limitations of neonatal intensive care, and the continuing health and developmental needs of these infants and their families.
2 ReferencesT. Allen Merritt, M.D.
University of California, Davis, Sacramento, CA 95817Bruce R. Boynton, M.D., M.P.H.
U.S. Naval Hospital, San Diego, CA 92134Mikko Hallman, M.D.
University of California, Irvine, Irvine, CA 927171
Stevenson D ,Walther F ,Long W , et al. Controlled trial of a single dose of synthetic surfactant at birth in premature infants weighing 500 to 699 gram. J Pediatr 1992;120:S3-S12[Erratum, J Pediatr 1992;120:762.]
CrossRef | Web of Science | Medline2
McCormick MC . Long-term follow-up of infants discharged from neonatal intensive care units. JAMA 1989;261:1767-1772
CrossRef | Web of Science | Medline
To the Editor:
Allen et al. have written a thought-provoking article not only on the outcome of infants born at 22 to 25 weeks' gestation but also on the moral and ethical issues surrounding their care.
For the past three years, when there is time for the discussion, our policy has been to offer the parents of infants soon to be born at 23 weeks' gestation the opportunity to be involved in the decision about whether invasive care will be offered to their infant in the delivery room. The maternal and neonatal risk factors are presented in full to the parents and the information given is tailored to their particular situation. After further discussion, the following approaches to the delivery-room care of the infant are offered, assuming that only a heartbeat is present at birth: comfort care only; manual stimulation and bag-and-mask ventilation to determine the infant's ability to respond, with the intervention ceasing and comfort care only being provided, except for oxygen therapy, if there is no response (i.e., no increase in heart rate and no attempt to breathe); and full invasive care including endotracheal intubation.
Since the initiation of this policy, all the parents have chosen full invasive care. This is not surprising, in view of the emotionally charged atmosphere that precedes the birth of any premature infant. It is not likely to be an environment conducive to analytic or rational thinking. Decisions are made on the basis of emotions that relate only to life or death. Few parents want to feel any more guilt than they already do about the premature birth of their child, and the thought of accruing further responsibility (and therefore guilt) for the death of their infant would be intolerable.
In the pre-Baby Doe era, such decisions were likely to be the sole responsibility of the physician in attendance in the delivery room, with the “comfort care only” option frequently exercised. Unilateral decisions are now much less common because parents have become the major partners in the decision-making process.
If changes in the response of the family to this situation are to occur, they must come from society at large. Only when society decides that the lives of these infants are worth too little or the price is too high will we not intervene. The authors have taken an important and courageous step by opening the discussion of this sensitive yet vital part of the health care debate.
Eileen E. Tyrala, M.D.
Temple University School of Medicine, Philadelphia, PA 19140-5189To the Editor:
The article by Allen et al.1 provides sorely needed objective data about outcomes for the smallest groups of neonates. This article and the accompanying editorial2 raise provocative questions about future directions in this area. However, both appear to share a flawed legal premise. Parents are not “partners in the decision-making process,”1 nor are their views to be given merely “careful consideration.” Parents are the decision makers; physicians who ignore a reasonable parental request risk serious consequences3-5.
The doctrine of informed consent requires the physician to assume the role of educator for the persons granting consent to treatment3,4. Although a prenatal exchange of information about newborn resuscitation can at times be difficult, it is rarely impossible. If possible, parents should be given site-specific information on outcomes, because the team at that site will care for their infant. Parents must then be allowed to make a reasonable choice among available treatment options, or perhaps choose nontreatment. Parents (and only parents) may include quality-of-life considerations in making their choice3. Parents can legally make a choice that the physician might not choose personally.
On the basis of the results presented by Allen et al.,1 it would be reasonable for the prospective parents of an infant born at 23 or 24 weeks' gestation at the Johns Hopkins Hospital to refuse consent for intervention on behalf of their infant. Physicians are legally obligated to honor this request or risk suit for committing battery. Since the outcome is good for over half of infants born at 25 weeks' gestation, parents who refuse consent for the resuscitation of such an infant might be making an unreasonable request, and the physician should consider seeking another authority for consent. In the case of the parents of an infant born at 23 or 24 weeks' gestation who do request resuscitation despite the poor prognosis, the physician is legally and ethically obligated to make the initial attempt3.
5 ReferencesFrank Clark, M.D., J.D.
University of Missouri, Columbia, MO 652121
Allen MC ,Donohue PK ,Dusman AE . The limit of viability -- neonatal outcome of infants born at 22 to 25 weeks' gestation. N Engl J Med 1993;329:1597-1601
Full Text | Web of Science | Medline2
Hack M ,Fanaroff AA . Outcomes of extremely immature infants -- a perinatal dilemma. N Engl J Med 1993;329:1649-1650
Full Text | Web of Science | Medline3
Clark FI . Withdrawal of life-support in the newborn: whose baby is it? Southwestern Univ Law Rev 1993;23:1-464
Clark FI. Intensive care treatment decisions: the roots of our confusion. Pediatrics (in press).
5
In re Joelle Rosebush, 491 N.W.2d 633 (Mich. App. 1992).
Author/Editor Response
The authors reply:
To the Editor: Whether the intensity of obstetrical or neonatal care has a major role in the mortality and morbidity among very preterm infants is a key issue. Unfortunately, without randomized clinical trials, which are unlikely to be approved by internal review boards, this question cannot be answered. We performed our study because of the paucity of data on outcomes in infants born at the limit of viability. There was some variability in the aggressiveness of approach among the obstetricians and neonatologists at our institution, and undoubtedly there is more variability throughout the country.
Infasurf was offered to all parents of infants born at less than 32 weeks' gestation and was administered prophylactically only to infants for whom written informed consent had been obtained before delivery. When a surfactant approved by the Food and Drug Administration became available, information about each surfactant was reviewed with parents, and they were given a choice. Almost no parent declined the use of surfactant therapy; the vast majority chose the surfactant with which we had had the most experience. Studies of the efficacy of surfactant therapy have not focused on infants born at the limit of viability. In fact, large randomized trials have excluded infants who weighed less than 600 to 700 g. In our experience, extremely preterm infants who were alive at the time of admission to the neonatal intensive care unit had improved survival, as compared with historical control patients, if they were treated prophylactically with Infasurf.1
Our experience mimics that of Dr. Tyrala in that most parents request full invasive care. Dr. Clark is correct that parents are the ultimate decision makers for their children. But neonatologists are far from impersonal educators. Few parents have given detailed thought to “what if” situations. To assume that physicians' experiences and beliefs do not factor into the decision-making process is naive. There is no doubt that long-term follow-up data on infants born at the limit of viability are essential for the care of such patients.
1 ReferencesMarilee C. Allen, M.D.
Pamela K. Donohue, M.S., P.A.-C.
Amy E. Dusman, R.N.C., M.A.S.
Johns Hopkins University, Baltimore, MD 21287
