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

Publication/Presentation Date

8-1-2021

Abstract

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.

Volume

41

Issue

8

First Page

2072

Last Page

2087

ISSN

1476-5543

Disciplines

Medicine and Health Sciences | Pediatrics

PubMedID

33758387

Department(s)

Department of Pediatrics

Document Type

Article

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