Dataset Information

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

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.

SUBMITTER: Adams-Chapman I

PROVIDER: S-EPMC8349854 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Adams-Chapman Ira I Watterberg Kristi L KL Nolen Tracy L TL Hirsch Shawn S Cole Carol A CA Cotten C Michael CM Oh William W Poindexter Brenda B BB Zaterka-Baxter Kristin M KM Das Abhik A Lacy Conra Backstrom CB Scorsone Ann Marie AM Duncan Andrea F AF DeMauro Sara B SB Goldstein Ricki F RF Colaizy Tarah T TT Wilson-Costello Deanne E DE Purdy Isabell B IB Hintz Susan R SR Heyne Roy J RJ Myers Gary J GJ Fuller Janell J Merhar Stephanie S Harmon Heidi M HM Peralta-Carcelen Myriam M Kilbride Howard W HW Maitre Nathalie L NL Vohr Betty R BR Natarajan Girija G Mintz-Hittner Helen H Quinn Graham E GE Wallace David K DK Olson Richard J RJ Orge Faruk H FH Tsui Irena I Gaynon Michael M Hutchinson Amy K AK He Yu-Guang YG Winter Timothy W TW Yang Michael B MB Haider Kathryn M KM Cogen Martin S MS Hug Denise D Bremer Don L DL Donahue John P JP Lucas William R WR Phelps Dale L DL Higgins Rosemary D RD

Journal of perinatology : official journal of the California Perinatal Association 20210323 8

<h4>Objective</h4>This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.<h4>Study design</h4>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 ...[more]

PMID: 33758387

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Project description:ImportancePrevious studies of myo-inositol in preterm infants with respiratory distress found reduced severity of retinopathy of prematurity (ROP) and less frequent ROP, death, and intraventricular hemorrhage. However, no large trials have tested its efficacy or safety.ObjectiveTo test the adverse events and efficacy of myo-inositol to reduce type 1 ROP among infants younger than 28 weeks' gestational age.Design, setting, and participantsRandomized clinical trial included 638 infants younger than 28 weeks' gestational age enrolled from 18 neonatal intensive care centers throughout the United States from April 17, 2014, to September 4, 2015; final date of follow-up was February 12, 2016. The planned enrollment of 1760 participants would permit detection of an absolute reduction in death or type 1 ROP of 7% with 90% power. The trial was terminated early due to a statistically significantly higher mortality rate in the myo-inositol group.InterventionsA 40-mg/kg dose of myo-inositol was given every 12 hours (initially intravenously, then enterally when feeding; n = 317) or placebo (n = 321) for up to 10 weeks.Main outcomes and measuresType 1 ROP or death before determination of ROP outcome was designated as unfavorable. The designated favorable outcome was survival without type 1 ROP.ResultsAmong 638 infants (mean, 26 weeks' gestational age; 50% male), 632 (99%) received the trial drug or placebo and 589 (92%) had a study outcome. Death or type 1 ROP occurred more often in the myo-inositol group vs the placebo group (29% vs 21%, respectively; adjusted risk difference, 7% [95% CI, 0%-13%]; adjusted relative risk, 1.41 [95% CI, 1.08-1.83], P = .01). All-cause death before 55 weeks' postmenstrual age occurred in 18% of the myo-inositol group and in 11% of the placebo group (adjusted risk difference, 6% [95% CI, 0%-11%]; adjusted relative risk, 1.66 [95% CI, 1.14-2.43], P = .007). The most common serious adverse events up to 7 days of receiving the ending dose were necrotizing enterocolitis (6% for myo-inositol vs 4% for placebo), poor perfusion or hypotension (7% vs 4%, respectively), intraventricular hemorrhage (10% vs 9%), systemic infection (16% vs 11%), and respiratory distress (15% vs 13%).Conclusions and relevanceAmong premature infants younger than 28 weeks' gestational age, treatment with myo-inositol for up to 10 weeks did not reduce the risk of type 1 ROP or death vs placebo. These findings do not support the use of myo-inositol among premature infants; however, the early termination of the trial limits definitive conclusions.

Dataset Information

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

Objective

Study design

Results

Conclusions

Publications

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

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