Inositol to Reduce Retinopathy of Prematurity

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Retinopathy of Prematurity (ROP)

In brief

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.

Key facts

Study ID

NCT01954082

Run by

NICHD Neonatal Research Network

People needed

638

Starts

2014-04-17

Expected to finish

2016-12-31

Last updated by the study team

2019-03-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inborn or out born infants of either gender or any race with best obstetrical estimate of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined by best obstetrical estimate using the hierarchy of best obstetrical estimate using early ultrasound dating, maternal menstrual dating confirmed by examination, or neonatal gestational age assessment by physical examination.
• Alive at 12 hours.
• Age in hours up to 72 hours, although we will seek enrollment as early as feasible after consent and 12 hours.
• Informed consent signed and dated by parent and/or guardian, which includes likelihood of completing follow-up ophthalmic examinations as an outpatient, and long-term follow-up.

You may not qualify if…

• Major congenital malformations
• Congenital malformations of the eye identified prior to randomization.
• Overt evidence of intrauterine congenital infections ("TORCH") or life threatening impairment of renal, hepatic, or cardiac function (considered moribund).

Where it is running

• 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
• RTI International — Durham, North Carolina, United States
• Duke University — 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

Full record on ClinicalTrials.gov

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