(HealthDay News) — For full-term neonates with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both do not reduce neonatal intensive care unit (NICU) death, according to a study published in the Dec. 24/31 issue of the Journal of the American Medical Association.
Seetha Shankaran, M.D., from Wayne State University in Detroit, and colleagues randomized neonates to four hypothermia groups: 33.5 degrees Celsius for 72 hours, 32.0 degrees Celsius for 72 hours, 33.5 degrees Celsius for 120 hours, and 32.0 degrees Celsius for 120 hours. The authors examined the safety and effectiveness of longer cooling and deeper cooling in neonates.
The trial was closed after enrollment of 364 of 726 planned neonates for emerging safety profile and futility analysis. The researchers found that for the 120 hour versus the 72 hour group, the adjusted risk ratio for NICU deaths was 1.37 (95 percent confidence interval, 0.92 to 2.04), and for the 32.0 degrees Celsius versus the 33.5 degrees Celsius group, the adjusted risk ratio was 1.24 (95 percent confidence interval, 0.69 to 2.25). Safety outcomes were similar between the groups, although major bleeding occurred among 1 and 3 percent, respectively, of the 120 and 72 hour groups (risk ratio, 0.25). In futility analysis, the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both was found to be less than 2 percent for NICU death.
“These results have implications for patient care and design of future trials,” the authors write.
One author disclosed financial ties to the pharmaceutical industry.