Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

Adams-Chapman I, Watterberg KL, Nolen TL, Hirsch S, Cole CA, Cotten CM, Oh W, Poindexter BB, Zaterka-Baxter KM, Das A, Lacy CB, Scorsone AM, Duncan AF, DeMauro SB, Goldstein RF, Colaizy TT, Wilson-Costello DE, Purdy IB, Hintz SR, Heyne RJ, Et al.

Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.

Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed.

Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).

Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.

Journal of Perinatology
Publication Date: 
Mar 23 2021
Pubmed ID: