Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00349726

Run by

NICHD Neonatal Research Network

People needed

74

Starts

2006-06-01

Expected to finish

2007-12-01

Last updated by the study team

2017-06-20

Who can join

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

You may qualify if…

• 23 0/7 to 26 6/7 weeks gestational age (36 infants) or
• 27 0/7 to 29 6/7 weeks gestational age (36 infants)
• 600-1500 grams birth weight
• No enteral feedings since birth at enrollment
• 3-6 days (25-132 hours) postnatal age
• Note: Because of the high mortality expected in this population (15-20%), the study design (originally for 72 infants) required recruitment of a replacement subject if any infant failed to complete the four blood samples during the first week of the study.

You may not qualify if…

• Major congenital anomalies
• Moribund or not to be provided continued support
• Renal failure suspected (creatinine >2.5 with oliguria)
• Exchange transfusion received or expected to receive

Where it is running

• Yale University — New Haven, Connecticut, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, 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
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, 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 Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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