Inositol to Reduce Retinopathy of Prematurity (INS-3)
Retinopathy of Prematurity (ROP)
About this trial
This is an interventional prevention trial for Retinopathy of Prematurity (ROP) focused on measuring Retinopathy, Prematurity, Infant, Newborn, Diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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).
Sites / Locations
- University of Alabama at Birmingham
- University of California - Los Angeles
- Stanford University
- Emory University
- Indiana University
- University of Iowa
- Wayne State University
- Children's Mercy Hospital
- University of New Mexico
- University of Rochester
- RTI International
- Duke University
- Cincinnati Children's Medical Center
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Research Institute at Nationwide Children's Hospital
- Univeristy of Pennsylvania
- Brown University, Women & Infants Hospital of Rhode Island
- University of Texas Southwestern Medical Center at Dallas
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
myo-Inositol 5% Injection
5% glucose(dextrose)
Within 12-72 hours of birth, infants will receive 80 mg myo-inositol 5% Injection per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours.
Within 12-72 hours of birth, infants will receive 80 mg 5% glucose(dextrose) USP for intravenous infusion per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours.