Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
This pilot study is 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 repeated doses 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 is to evaluate pharmacokinetics, safety, and clinical outcomes of multiple doses of
three different dose amounts of myo-inositol (provided by Abbott Laboratories) in very low
birth weight premature infants. This study will enroll an estimated 96 infants at 17 NICHD
Neonatal Research Network sites. Infants will be randomly assigned to receive either 10 mg/kg
of 5% inositol, 40 mg/kg of 5% inositol, 80 mg/kg of 5% inositol, or 5% glucose given in the
same volumes and timings as the inositol dosage to maintain masking. Enrollees will receive
their assigned dose or placebo daily, starting within 72 hours of birth, and continuing until
they reach 34 weeks post-menstrual age, 10 weeks chronologic age, or until the time of
hospital discharge, whichever occurs first. The study drug will be administered first
intravenously; as the infants progress to full feeding, the drug will be given enterally
(orally or via feeding tube). Enrollees will be seen for a follow-up examination at 18-22
months corrected age. This pilot study is in preparation for a future Phase III multi-center
randomized controlled trial.
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)