Clinical Trials Okay for Extreme Preemies
Think extremely premature infants can’t be enrolled in clinical trials because it’s too risky? Think again. New research shows that extremely premature infants who take part in randomized clinical trials don’t have worse outcomes while in the hospital compared to those who aren’t part of any trials.
The research included more than 5,000 extremely premature infants — born after just 22 weeks to 28 weeks gestation. About 3,800 babies were enrolled in at least one of six randomized clinical trials and nearly 1,600 were eligible but weren’t enrolled in any of the trials.
The primary outcome — a composite of death, a chronic lung disorder, severe brain injury, or a sight-threatening eye problem — didn’t vary significantly between the two groups. Sixty-eight percent of the enrolled infants and 69 percent of the non-enrolled infants had those problems.
The study was published June 16 in the journal JAMA.
Research published in the New England Journal of Medicine shows that hospital practices vary widely, as do rates of survival and survival without severe impairment, in initiating active treatment in extremely premature babies.
Across two dozen hospitals, and out of nearly 5,000 infants born prior to reaching 27 weeks, overall rates of active treatment ranged from 22.1% among infants born at 22 weeks of gestation to 99.8% among those born at 26 weeks of gestation, according to Edward F. Bell, MD, of the University of Iowa in Iowa City, and colleagues.
Bell’s team looked at 24 hospitals in the Eunice Kennedy Shriver