Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
Public ClinicalTrials.gov record NCT00349726. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00349726
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Interventions
- Inositol lower volume Drug
- Inositol higher volume Drug
- Placebo lower volume Drug
- Placebo higher volume Drug
Drug
Eligibility (public fields only)
- Age range
- 3 Days to 6 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2006
- Primary completion
- Nov 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- Jun 19, 2017
2006 – 2007
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06504 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00349726, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 19, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00349726 live on ClinicalTrials.gov.