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NCT00349726 · ClinicalTrials.gov registry record · Phase 2
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
A Phase 2 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
NCT00349726: Completed Phase 2 study, sponsored by NICHD Neonatal Research Network.
NCT00349726 is a Phase 2 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00349726, a Phase 2 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
Study 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.
Interventions
- DRUG Inositol lower volume
- DRUG Inositol higher volume
- DRUG Placebo lower volume
- DRUG Placebo higher volume
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2006-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00349726 record still lists
NCT00349726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 4 interventions - of which Inositol lower volume is the first listed.
NCT00349726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00349726 about?
NCT00349726 is a clinical study titled "Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants". 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 mainta...
What is the current status of trial NCT00349726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2006-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00349726?
The interventions under investigation include: Inositol lower volume (DRUG), Inositol higher volume (DRUG), Placebo lower volume (DRUG), Placebo higher volume (DRUG).
Who is sponsoring clinical trial NCT00349726?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00349726's enrollment target sits among peer trials
74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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