Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 74 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00349726
The ClinicalTrials.gov registry entry for NCT00349726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Inositol lower volume is the first listed.
NCT00349726 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.