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Preterm infants are not adversely affected by enrollment in RCTs
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Recent study findings showed that extremely preterm infants enrolled in randomized clinical trials are not impacted negatively or positively, when compared to infants who are not enrolled.
“The present study did not find differences in mortality or neonatal morbidity between trial participants and nonparticipants,” Elizabeth E. Foglia, MD, and colleagues wrote in the JAMA. “Similarly, meta-analyses of studies of adults and older children have demonstrated no significant differences in outcomes between trial participants and nonparticipants who were treated similarly outside trials.”
The researchers conducted a retrospective analysis of six randomized clinical trials, forming a cohort of 5,389 extremely preterm infants. There were 3,795 infants included in at least one randomized clinical trial and 1,594 infants not enrolled in a randomized clinical trial.
Study results found no significant differences between the enrolled (68%) and nonenrolled groups (69%) when comparing outcomes such as death, bronchopulmonary dysplasia, severe brain injury and severe retinopathy of prematurity (OR = 1.08; 95% CI, 0.93-1.26; P = .29).
Secondary outcomes that included individual components of the primary outcomes, such as culture-proven late-onset sepsis and necrotizing enterocolitis, were also compared between the two groups. There were no significant differences between the two groups.
Researchers suggest that these study results can be used to relieve concerns other researchers may have about conducting randomized clinical trials involving this vulnerable population.
“In a cohort of more than 5,000 extremely preterm infants, important in-hospital outcomes were neither better nor worse in infants enrolled in [randomized clinical trials] compared with eligible but non-enrolled infants. These findings may reassure those who have concerns about performing [randomized clinical trials] in this vulnerable population,” Foglia and colleagues wrote. – by David Costill
Disclosure: The researchers report no relevant financial disclosures.
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