Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

Summary

This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective was to evaluate the single-dose pharmacokinetics and safety of different amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight neonates, in preparation for a future Phase III multi-center randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9 NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Retinopathy of Prematurity
• Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Inositol lower volume

60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

DRUG

Inositol higher volume

120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

DRUG

Placebo lower volume

60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.

DRUG

Placebo higher volume

120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

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

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

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

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

• Ronald N. Goldberg, MD · Duke University

• Brenda B. Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Kristi L. Watterberg, MD · University of New Mexico

• Dale L. Phelps, MD · University of Rochester

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Roger G. Faix, MD · University of Utah

• Barbara J. Stoll, MD · Emory University

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

• 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

• Ivan D. Frantz, III, MD · Tufts Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Days

Max Age

6 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2007-12-31

Completion

2007-12-31

FDA Drug

Yes

Countries

• United States

Study Locations