1. In this randomized controlled trial, both mortality and retinopathy of prematurity (ROP) type 1 occurred more often in preterm infants treated with myo-inositol than in those treated with placebo.
2. Necrotizing enterocolitis and hypotension were noticable adverse effects in the Myo-inositol group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: A common morbidity in preterm infants is ROP. Previous studies conducted up to 2 decades ago and a more recent Cochrane meta-analysis have shown the benefits of myo-inositol in reducing pre-term death and ROP. In this randomized controlled trial, the safety and efficacy of this treatment in infants younger than 28 weeks’ gestation in reducing rates of type 1 ROP was tested against placebo. Infants treated with myo-inositol had higher rates of mortality and type 1 than infants treated with placebo. Common adverse effects of myo-inositol were necrotizing enterocolitis, poor perfusion, hypotension, and intraventricular hemorrhage.
Overall, this study suggests the opposite result of other analyses, namely that myo-inositol may increase the rate of death and type 1 ROP in preterm infants. Limitations of this study include inadequate sample size to make definitive conclusions regarding efficacy and not being formally powered to make conclusions regarding safety of myo-inositol. Early termination of the trial also limited definitive conclusions.
Relevant Reading: Inositol for respiratory distress syndrome in preterm infants
In-Depth [randomized controlled trial]: The study was a double-blind placebo-controlled randomized clinical trial. Inclusion criteria included infants born before 28 0/7 weeks of gestation, surviving for at least 12 hours, and admitted to one of the participating centers before 72 hours’ postnatal age. Exclusion criteria included any major congenital anomaly, eye anomaly, or moribund condition. Randomization was done using computer-generated methods. The treatment dose was 40 mg/kg every 12 hours of myo-inositol (or placebo which was 5% glucose) for 10 weeks. The primary unfavorable outcome was type 1 ROP or death before the ROP outcome could be realized. The favorable primary outcome was survival with only milder ROP or no ROP. Infants were followed up to maximum of 55 weeks’ post-menstrual age. Secondary outcomes included occurrence of any type of ROP, self-resolving type 2 ROP or greater, and all-cause mortality up to 55 weeks’ post-menstrual age. Overall, death and type 1 ROP occurred more frequently in the myo-inositol group (29% vs 21%, adjusted relative risk, 1.41; CI95 1.08-1.83). All-cause death before 55 weeks’ post-menstrual age also occurred more frequently in the myo-inositol group (18% vs 11%, adjusted relative risk, 1.66; CI95 1.14-2.43).
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