Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)

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 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.

Key facts

Study ID

NCT01030575

Run by

NICHD Neonatal Research Network

People needed

125

Starts

2010-01-01

Expected to finish

2013-09-01

Last updated by the study team

2022-06-14

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 23 0/7 to 26 6/7 weeks gestational age (48 infants) or
• 27 0/7 to 29 6/7 weeks gestational age (48 infants)
• 401 grams birth weight or larger
• 12-72 hours of age

You may not qualify if…

• Major congenital and intracranial anomalies
• Moribund or not to be provided continued support
• Seizures
• Suspected renal failure (oliguria <0.6 cc/kg/hr for >24 hours or creatinine >2.5 mg/dL)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, 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 Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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