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Clinical trialNCT01954082TerminatedPhase 3Interventional

Inositol to Reduce Retinopathy of Prematurity

SponsorNICHD Neonatal Research NetworkEnrollment638Retinopathy of Prematurity (ROP)
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants \<28 0/7 weeks' gestation.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • University of California - Los Angeles

    Los Angeles, California, United States

  • Stanford University

    Palo Alto, California, United States

  • Emory University

    Atlanta, Georgia, United States

  • Indiana University

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Wayne State University

    Detroit, Michigan, United States

  • Children'S Mercy Hospital

    Kansas City, Missouri, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • University of Rochester

    Rochester, New York, United States

  • Duke University

    Durham, North Carolina, United States

  • Rti International

    Durham, North Carolina, United States

  • Cincinnati Children'S Medical Center

    Cincinnati, Ohio, United States

  • Case Western Reserve University, Rainbow Babies and Children'S Hospital

    Cleveland, Ohio, United States

  • Research Institute at Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboMyo-Inositol 5% Injection
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
17 Apr 2014
Primary completion
31 Dec 2016
Completion
31 Dec 2016
Last update posted
22 Mar 2019
Registered enrollment
638
Registry id
NCT01954082

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.