Extreme 'Preemie' Infants at No Higher Risk If Included in Clinical Trials

Study found similar rates of adverse events

By Robert Preidt

Tuesday, June 16, 2015

TUESDAY, June 16, 2015 (HealthDay News) -- 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 such research, a new study finds.

The researchers undertook the study because it wasn't known if taking part in randomized clinical trials posed a risk to extremely premature infants. These findings may help ease concerns, according to Dr. Elizabeth Foglia, University of Pennsylvania, and colleagues.

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.

There were also no differences between the two groups when the researchers looked at those complications individually. In addition, there were no differences between the two groups for rates of sepsis (an infection of the bloodstream), and necrotizing enterocolitis (severe inflammation of the intestines caused by reduced blood flow).

The study was published June 16 in the journal JAMA.

SOURCE: JAMA, news release, June 16, 2015

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