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NCT01193270 · ClinicalTrials.gov registry record · Phase 1
Vitamin E for Extremely Preterm Infants
A Phase 1 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
NCT01193270 is a Phase 1 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 93 participants.
The verdict
NCT01193270, a Phase 1 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth weight). This pilot will examine whether a single dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum α-tocopherol level in the target range of 1-3 mg/dl.
Interventions
- DRUG Placebo
- DRUG Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01193270
The ClinicalTrials.gov registry entry for NCT01193270 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 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 2 interventions - of which Placebo is the first listed.
NCT01193270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01193270 about?
NCT01193270 is a clinical study titled "Vitamin E for Extremely Preterm Infants". The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth weight). This pilot will examine whether a single dose of vitamin E will b...
What is the current status of trial NCT01193270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2010-10. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01193270?
The interventions under investigation include: Placebo (DRUG), Vitamin E (DRUG).
Who is sponsoring clinical trial NCT01193270?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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