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NCT01030575 · ClinicalTrials.gov registry record · Phase 2
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
A Phase 2 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT01030575 is a Phase 2 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 125 participants.
The verdict
NCT01030575, a Phase 2 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Inositol lower volume
- DRUG Inositol mid-level volume
- DRUG Inositol high volume
- DRUG Placebo low volume
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01030575
The ClinicalTrials.gov registry entry for NCT01030575 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 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.
NCT01030575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01030575 about?
NCT01030575 is a clinical study titled "Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)". 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 inosit...
What is the current status of trial NCT01030575?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2010-01. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01030575?
The interventions under investigation include: Inositol lower volume (DRUG), Inositol mid-level volume (DRUG), Inositol high volume (DRUG), Placebo low volume (DRUG).
Who is sponsoring clinical trial NCT01030575?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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