No reduction in risk for type 1 ROP or death with myo-inositol versus placebo in preemies <28 weeks
WEDNESDAY, Oct. 24, 2018 (HealthDay News) — Treatment with myo-inositol for up to 10 weeks does not reduce the risk for type 1 retinopathy of prematurity (ROP) or death versus placebo for premature infants younger than 28 weeks of gestational age, according to a study published in the Oct. 23/30 issue of the Journal of the American Medical Association.
Dale L. Phelps, M.D., from the University of Rochester in New York, and colleagues conducted a randomized clinical trial involving 638 infants younger than 28 weeks of gestational age enrolled from 18 neonatal intensive care centers throughout the United States. Infants were randomly assigned to receive either a 40-mg/kg dose of myo-inositol given every 12 hours (317 infants) or placebo (321 infants) for up to 10 weeks.
The planned enrollment was 1,760 participants; however, the trial was terminated early due to a statistically significantly higher mortality rate in the myo-inositol group. The researchers found that infants in the myo-inositol group more often died or had type 1 ROP compared with the placebo group (29 versus 21 percent; adjusted relative risk, 1.41). Overall, 18 percent of the myo-inositol group and 11 percent of the placebo group had all-cause death before 55 weeks of postmenstrual age (adjusted relative risk, 1.66).
“These findings do not support the use of myo-inositol among premature infants; however, the early termination of the trial limits definitive conclusions,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
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