At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
In Brief
A Phase 2 clinical trial evaluating Inositol lower volume, Inositol higher volume, and 2 other interventions for Infant, Newborn and 5 related conditions. Completed, enrolled 74 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.
120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.