Do sick newborn infants benefit from participation in a randomized clinical trial?☆,☆☆
Section snippets
Selection of Patients
This study took place at McMaster University Medical Center from November 1992 to February 1996 in a 33-bed neonatal intensive care unit that serves a regional population of 1.8 million people. Approximately 1000 newborn infants are admitted annually, of whom 80% are born in the center; the remainder are referred from surrounding hospitals.
Premature infants were eligible for enrollment in a placebo-controlled trial of antithrombin therapy if they fulfilled all of the following inclusion
RESULTS
During the study period 224 infants were identified who met all inclusion criteria, 198 of whom had no exclusion criteria present and were thus eligible. One hundred twenty-two of these eligible subjects were randomized, 61 of them to placebo. The most frequent reason for not randomizing an eligible patient was lack of informed parental consent (n = 38); the families of 24 patients were not approached (usually because of an administrative oversight). Randomization was also suspended for a short
DISCUSSION
Premature infants with moderate to severe respiratory distress syndrome who were eligible but not randomized in a recent investigational drug trial of antithrombin therapy appeared to have worse immediate outcomes than infants who had been allocated to the placebo arm of the controlled trial. Although the results of any nonrandomized comparison must be interpreted with caution, the validity of our observation is enhanced by the close balance at baseline for most important prognostic factors in
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Cited by (64)
Towards evidence-based resuscitation of the newborn infant
2017, The LancetCitation Excerpt :Non-enrolled infants were small, less mature, in poor condition at birth, and were likely to need advanced resuscitation; consequently, these infants had high rates of mortality and morbidities.98 Findings from an investigational drug trial99 also showed that newborn infants who were allocated to receive placebo had better outcomes than infants who were eligible but not randomised—a finding that has been replicated in adult randomised controlled trial participants.100,101 These data raise the possibility of using retrospective or deferred consent (also known as waiver of consent) for studies in the delivery room.102,103
Clinical Trials
2017, Clinical and Translational Science: Principles of Human Research: Second EditionThe ethics of neonatal research: A trialists' perspective
2015, Seminars in Fetal and Neonatal MedicineCitation Excerpt :However, few studies have evaluated the effect of trial participation on outcomes of premature and sick newborns. These studies differed in design and had diverging findings [37,43]. Therefore, we recently compared clinical outcomes between infants who were enrolled in randomized trials conducted by the Neonatal Research Network of the United States National Institute of Child Health and Human Development and infants who were eligible but not enrolled [44].
The ethics of neonatal research: An ethicist's and a parents' perspective
2015, Seminars in Fetal and Neonatal MedicineFluoroscopic versus laparoscopic implantation of peritoneal dialysis catheters: A retrospective cohort study
2014, Journal of Vascular and Interventional RadiologyEthical support for surfactant, positive pressure, and oxygenation randomized trial (SUPPORT)
2013, Journal of Pediatrics
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Reprint requests: Barbara Schmidt, MD, Department of Pediatrics, McMaster University, 1200 Main St West, Room HSC 3N11E, Hamilton, Ontario, Canada L8N 3Z5.
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0022-3476/99/$8.00 + 0 9/21/95273