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Centre for Evidence-
Based Medicine

Introduction to evidence-based neonatal medicine

Although neonatologists, together with obstetricians, were pioneers in performing systematic reviews for the Oxford database of perinatal trials, neonatal medicine has also had its share of "well-intentioned" disasters: Therapies were introduced without rigorous evaluation and subsequently found to do more harm than good. William A. Silverman's sobering monograph "Retrolental Fibroplasia: A Modern Parable" (see resources) is a "must-read" for all health professionals involved in neonatal care. An "obviously" beneficial therapy such as oxygen for periodic breathing in premature infants was belatedly found to cause severe retinal disease and blindness, which was proven only in properly well-designed controlled clinical trials.

Proponents of sound clinical investigations in newborn infants are frequently asked to defend the ethics of research in this vulnerable population. Many of the arguments against rigorous experimentation in infants have been developed by "ivory tower" ethicists - there is a striking lack of empirical research on the attitudes of parents and the outcomes of infants who participate in clinical trials.

At McMaster, we recently completed the first study to correlate the determinants of parental authorization for the involvement of newborn infants in clinical trials with the direction of the consent decision. We were reassured to find no association between the consent decision and the sociodemographic characteristics of the parents, or the severity of the infant's illness. Moreover, we showed that parents assessed the probability and magnitude of risks and benefits. Most importantly, those parents who did not feel free to decide or who felt that the consent process was too complex, were, in fact, least likely to authorize their infant's participation in a clinical trial (Zupancic JAF, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997:99.)

In a separate study, we provided evidence suggesting that the outcomes of newborn infants who participate in the placebo group of an investigational drug trial are at least as good and likely better than the outcomes of eligible non-participants (Schmidt B, Gillie P, Caco C, Roberts J, Roberts R. Do sick newborn infants benefit from participation in a randomized clinical trial? J Pediatr 1999;134:151-155).

More studies of this nature are needed to ensure that the field of neonatal research ethics becomes "evidence-based".