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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: Completed Phase 1 study, sponsored by NICHD Neonatal Research Network.
NCT01193270 is a Phase 1 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 93 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples will be tested for tocopherol levels at baseline, 24 hours, and 7 days.
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 |
What the finished NCT01193270 record still lists
NCT01193270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01193270 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01193270's enrollment target sits among peer trials
93 624th of 2000 higher than 1,376 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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