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

for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

doi:10.1038/s41372-021-01018-5

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

for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

Emory University
University of New Mexico
RTI International
University of Rochester
Duke University
Brown University
University of Cincinnati
Indiana University Bloomington
University of Texas Health Science Center at Houston
Children's Hospital of Philadelphia
University of Iowa
Case Western Reserve University
University of California at Los Angeles
Stanford University
University of Texas Southwestern Medical Center
University of Alabama at Birmingham
University of Missouri at Kansas City
Ohio State University
Wayne State University
Nationwide Children’s Hospital

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English
Pages (from-to)	2072-2087
Number of pages	16
Journal	Journal of Perinatology
Volume	41
Issue number	8
DOIs	https://doi.org/10.1038/s41372-021-01018-5
State	Published - Aug 2021

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10.1038/s41372-021-01018-5

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@article{6418b2839dcd41648ffb4ccf09aeb37b,

title = "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.",

author = "\{for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network\} and Ira Adams-Chapman and Watterberg, \{Kristi L.\} and Nolen, \{Tracy L.\} and Shawn Hirsch and Cole, \{Carol A.\} and Cotten, \{C. Michael\} and William Oh and Poindexter, \{Brenda B.\} and Zaterka-Baxter, \{Kristin M.\} and Abhik Das and Lacy, \{Conra Backstrom\} and Scorsone, \{Ann Marie\} and Duncan, \{Andrea F.\} and DeMauro, \{Sara B.\} and Goldstein, \{Ricki F.\} and Colaizy, \{Tarah T.\} and Wilson-Costello, \{Deanne E.\} and Purdy, \{Isabell B.\} and Hintz, \{Susan R.\} and Heyne, \{Roy J.\} and Myers, \{Gary J.\} and Janell Fuller and Stephanie Merhar and Harmon, \{Heidi M.\} and Myriam Peralta-Carcelen and Kilbride, \{Howard W.\} and Maitre, \{Nathalie L.\} and Vohr, \{Betty R.\} and Girija Natarajan and Helen Mintz-Hittner and Quinn, \{Graham E.\} and Wallace, \{David K.\} and Olson, \{Richard J.\} and Orge, \{Faruk H.\} and Irena Tsui and Michael Gaynon and Hutchinson, \{Amy K.\} and He, \{Yu Guang\} and Winter, \{Timothy W.\} and Yang, \{Michael B.\} and Haider, \{Kathryn M.\} and Cogen, \{Martin S.\} and Denise Hug and Bremer, \{Don L.\} and Donahue, \{John P.\} and Lucas, \{William R.\} and Phelps, \{Dale L.\} and Reynolds, \{Anne Marie\} and Michele Hartley-McAndrew and Osman Farooq",

note = "Publisher Copyright: {\textcopyright} 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.",

year = "2021",

month = aug,

doi = "10.1038/s41372-021-01018-5",

language = "English",

volume = "41",

pages = "2072--2087",

journal = "Journal of Perinatology",

issn = "0743-8346",

publisher = "Springer Nature",

number = "8",

}

TY - JOUR

T1 - Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

AU - for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

AU - Adams-Chapman, Ira

AU - Watterberg, Kristi L.

AU - Nolen, Tracy L.

AU - Hirsch, Shawn

AU - Cole, Carol A.

AU - Cotten, C. Michael

AU - Oh, William

AU - Poindexter, Brenda B.

AU - Zaterka-Baxter, Kristin M.

AU - Das, Abhik

AU - Lacy, Conra Backstrom

AU - Scorsone, Ann Marie

AU - Duncan, Andrea F.

AU - DeMauro, Sara B.

AU - Goldstein, Ricki F.

AU - Colaizy, Tarah T.

AU - Wilson-Costello, Deanne E.

AU - Purdy, Isabell B.

AU - Hintz, Susan R.

AU - Heyne, Roy J.

AU - Myers, Gary J.

AU - Fuller, Janell

AU - Merhar, Stephanie

AU - Harmon, Heidi M.

AU - Peralta-Carcelen, Myriam

AU - Kilbride, Howard W.

AU - Maitre, Nathalie L.

AU - Vohr, Betty R.

AU - Natarajan, Girija

AU - Mintz-Hittner, Helen

AU - Quinn, Graham E.

AU - Wallace, David K.

AU - Olson, Richard J.

AU - Orge, Faruk H.

AU - Tsui, Irena

AU - Gaynon, Michael

AU - Hutchinson, Amy K.

AU - He, Yu Guang

AU - Winter, Timothy W.

AU - Yang, Michael B.

AU - Haider, Kathryn M.

AU - Cogen, Martin S.

AU - Hug, Denise

AU - Bremer, Don L.

AU - Donahue, John P.

AU - Lucas, William R.

AU - Phelps, Dale L.

AU - Reynolds, Anne Marie

AU - Hartley-McAndrew, Michele

AU - Farooq, Osman

PY - 2021/8

Y1 - 2021/8

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85103247984

U2 - 10.1038/s41372-021-01018-5

DO - 10.1038/s41372-021-01018-5

M3 - Article

C2 - 33758387

AN - SCOPUS:85103247984

SN - 0743-8346

VL - 41

SP - 2072

EP - 2087

JO - Journal of Perinatology

JF - Journal of Perinatology

IS - 8

ER -

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

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