Evidence map›Paper›PMID 34686832›Full record

ArticlePediatric research2023

Relationships between retinopathy of prematurity without ophthalmologic intervention and neurodevelopment and vision at 2 years.

Jane E Brumbaugh, Edward F Bell, Shawn C Hirsch, Emma G Crenshaw, Sara B DeMauro, Ira S Adams-Chapman, Jean R Lowe, Girija Natarajan, Myra H Wyckoff, Betty R Vohr and 5 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Pediatric research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01954082 (INS-3), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01954082 phase3terminatednot on this map

INS-3: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Myo-Inositol 5% Injection to Increase Survival Without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants

TypeinterventionalSponsorNICHD Neonatal Research NetworkRan2014 to 2016Enrolled638ConditionsRetinopathy of Prematurity (ROP)Armsmyo-Inositol 5% Injection, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
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  4. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 1 country.

Jane E BrumbaughDepartment of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA.
Edward F BellDepartment of Pediatrics, University of Iowa, Iowa City, IA, USA. edward-bell@uiowa.edu.
Shawn C HirschBiostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC, USA.
Emma G CrenshawBiostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC, USA.
Sara B DeMauroDepartment of Pediatrics, University of Pennsylvania, Philadelphia, PA, USA.
Ira S Adams-ChapmanDepartment of Pediatrics, Emory University, Atlanta, GA, USA.
Jean R LoweDepartment of Pediatrics, University of New Mexico, Albuquerque, NM, USA.
Girija NatarajanDepartment of Pediatrics, Wayne State University, Detroit, MI, USA.
Myra H WyckoffDepartment of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Betty R VohrDepartment of Pediatrics, Brown University, Providence, RI, USA.
Tarah T ColaizyDepartment of Pediatrics, University of Iowa, Iowa City, IA, USA.
Heidi M HarmonDepartment of Pediatrics, University of Iowa, Iowa City, IA, USA.
Kristi L WatterbergDepartment of Pediatrics, University of New Mexico, Albuquerque, NM, USA.
Susan R HintzDepartment of Pediatrics, Stanford University, Palo Alto, CA, USA.
Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
University of Iowa · USRTI International · USUniversity of New Mexico · USBrown University · USEmory University · USMayo Clinic in Florida · USPalo Alto University · USThe University of Texas Southwestern Medical Center · USUniversity of Pennsylvania · USWayne State University · US

Funding

Neonatal Research Network Data Coordinating Center (DCC) 2023-2028U24HD095254 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI Abhik Das · 2018 to 2026
$70.2M
Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI LAPTOOK, ABBOT R · 1991 to 2015
$8.7M
NICHD Neonatal Research Network -- Cincinnati Clinical CenterUG1HD027853 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI STEPHANIE L MERHAR · 2016 to 2026
$3.7M
Clinical Center for NICHD/Neonatal Research NetworkUG1HD068244 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Sara Bonamo DeMauro, Eric C Eichenwald · 2016 to 2026
$3.6M
NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORKUG1HD040689 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI Myra Helen Wyckoff · 2016 to 2026
$3.5M
NICHD Neonatal Research Network Clinical Center - Case Western Reserve UniversityUG1HD021364 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI Anna Maria Hibbs · 2016 to 2026
$3.5M
North Carolina Clinical CenterUG1HD040492 · NICHD · DUKE UNIVERSITY · PI CHARLES Michael COTTEN, Matthew Laughon · 2016 to 2026
$3.4M
NICHD Cooperative Multicenter Neonatal Research Network - Utah CenterUG1HD087226 · NICHD · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI ROBIN K OHLS · 2016 to 2026
$3.3M
NICHD Neonatal Research Network - Stanford UniversityUG1HD027880 · NICHD · STANFORD UNIVERSITY · PI Valerie Chock · 2016 to 2026
$3.3M
NICHD Neonatal Research Network Clinical Center UABUG1HD034216 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WALDEMAR A. CARLO FONT · 2016 to 2026
$3.3M
NCATS NIH HHS UL1 TR001117NICHD NIH HHS U10 HD027904NICHD NIH HHS U10 HD036790NICHD NIH HHS U24 HD095254NICHD NIH HHS UG1 HD021364NICHD NIH HHS UG1 HD021385NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD027856NICHD NIH HHS UG1 HD027880NICHD NIH HHS UG1 HD027904NICHD NIH HHS UG1 HD034216NICHD NIH HHS UG1 HD040492NICHD NIH HHS UG1 HD040689NICHD NIH HHS UG1 HD053089NICHD NIH HHS UG1 HD053109NICHD NIH HHS UG1 HD068244NICHD NIH HHS UG1 HD068263NICHD NIH HHS UG1 HD068270NICHD NIH HHS UG1 HD068278NICHD NIH HHS UG1 HD068284NICHD NIH HHS UG1 HD087226NICHD NIH HHS UG1 HD087229NICHD NIH HHS UG1 HD104252
6 · The paper itself

Abstract

backgroundSevere retinopathy of prematurity (ROP) is associated with adverse outcomes. Relationships between milder ROP and outcomes have not been defined. We hypothesized that children with ROP stage ≤3 who did not receive ophthalmologic intervention would have worse motor, cognitive, and language skills and more vision abnormalities than children without ROP.

methodsThis was a secondary analysis of a randomized trial evaluating the effects of myo-inositol on ROP in the NICHD Neonatal Research Network. Primary outcomes were Bayley Scales of Infant Development composite scores; secondary outcomes included behavioral difficulties and ophthalmologic measures. Outcomes were compared using adjusted linear or modified Poisson models.

resultsOf 506 children, 173 (34%) had no ROP, 262 (52%) had ROP stage ≤3 without intervention, and 71 (14%) had ROP with intervention. There was no difference in motor, cognitive, or language scores between children with ROP stage ≤3 without intervention and children without ROP. Children with ROP stage ≤3 without intervention had a higher rate of strabismus compared to children without ROP (p = 0.040).

conclusionChildren with ROP stage ≤3 without intervention did not have adverse neurodevelopmental outcomes at 2 years' corrected age compared to children without ROP but did have an increased incidence of strabismus. IMPACT: This study addresses a gap in the literature regarding the relationship between milder forms of retinopathy of prematurity (ROP) that regress without intervention and neurodevelopment and vision outcomes. Children with a history of ROP stage ≤3 without intervention have similar neurodevelopmental outcomes at 2 years' corrected age as children born extremely preterm without a history of ROP and better outcomes than children with a history of ROP with ophthalmologic intervention. Counseling about likely neurodevelopment and vision outcomes for children born extremely preterm with a history of ROP may be tailored based on the severity of ROP. CLINICAL

trial registrationClinicalTrials.gov ID: Inositol to Reduce Retinopathy of Prematurity Trial: NCT01954082.

Indexed as

Infant, Newborn, DiseasesRetinopathy of PrematurityStrabismusChildGestational AgeHumansInfantInfant, NewbornInfant, PrematureInositolInositol

Identifiers

PMID34686832
PMCPMC9023615
OpenAlexW3205141205

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.