NCT00349726: INS-1

Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

Completed Phase 2 Last updated 19 June 2017

What this trial tests

Phase 2 trial testing Inositol lower volume in Infant, Newborn in 74 participants. Completed in 1 December 2007.

Timeline

1 June 2006

Primary endpoint
1 December 2007

1 December 2007

Quick facts

Lead sponsor	NICHD Neonatal Research Network
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	74
Start date	1 June 2006
Primary completion	1 December 2007
Estimated completion	1 December 2007
Sites	11 locations across United States

Drugs / interventions tested

• Inositol lower volume — full drug profile →
• Inositol higher volume — full drug profile →
• Placebo lower volume — full drug profile →
• Placebo higher volume — full drug profile →

Conditions studied

• Infant, Newborn — all drugs for Infant, Newborn →
• Infant, Low Birth Weight — all drugs for Infant, Low Birth Weight →
• Infant, Small for Gestational Age — all drugs for Infant, Small for Gestational Age →
• Infant, Premature — all drugs for Infant, Premature →

Sponsor

NICHD Neonatal Research Network

Who can join

Adults 3 Days to 6 Days, any sex, with Infant, Newborn or Infant, Low Birth Weight. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Population pharmacokinetics
  Time frame: 0-100 hours following infusion

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Retinopathy of prematurity.
   Hellström A, Smith LE, Dammann O. · · 2013 · cited 721× · PMID 23782686 · DOI 10.1016/s0140-6736(13)60178-6
2. Inositol in preterm infants at risk for or having respiratory distress syndrome.
   Howlett A, Ohlsson A, Plakkal N. · · 2019 · cited 26× · PMID 31283839 · DOI 10.1002/14651858.cd000366.pub4
3. Pharmacokinetics and safety of a single intravenous dose of myo-inositol in preterm infants of 23-29 wk.
   Phelps DL, Ward RM, Williams RL, Watterberg KL, et al · · 2013 · cited 18× · PMID 24067395 · DOI 10.1038/pr.2013.162
4. Retinopathy of prematurity.
   · 1991 · cited 5× · PMID 1670732 · DOI 10.1201/b15762-7