Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR) National Eye Institute (NEI)