Inositol to Reduce Retinopathy of Prematurity

Summary

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.

Conditions

• Retinopathy of Prematurity (ROP)

Interventions

DRUG

myo-Inositol 5% Injection

Abbott Nutrition Division, Abbott Laboratories is supplying myo-Inositol 5% Injection to the clinical centers for the duration of the trial. Inositol: myo-Inositol 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. It is administered via IV infusion using syringe pump over 15-30 minutes twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose).

DRUG

Placebo

% glucose(dextrose)

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Michele C Walsh, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Abhik Das, PhD · RTI International

• Seetha Shankaran, MD · Wayne State University

• Barbara J Stoll, MD · Emory University

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Greg Sokol, MD · Indiana University

• Abbot R Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Krisa P Van Meurs, MD · Stanford University

• Waldemar A Carlo, MD · University of Alabama at Birmingham

• Kathleen A Kennedy, MD, MPH · The University of Texas Health Science Center, Houston

• Ronald N Goldberg, MD · Duke University

• Edward F Bell, MD · University of Iowa

• Dale L Phelps, MD · University of Rochester

• Carl T D'Angio, MD · University of Rochester

• William Truog, MD · Children's Mercy Hospital Kansas City

• Pablo Sanchez, MD · Research Institute at Nationwide Children's Hospital

• Uday Devaskar, MD · University of California, Los Angeles

• Myra Wyckoff, MD · University of Texas at Southwestern

• Kristi L Watterberg, MD · University of New Mexico

• Barbara Schmidt, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Hours

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-17

Primary Completion

2016-12-31

Completion

2016-12-31

FDA Drug

Yes

Countries

• United States

Study Locations