CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 93 enrolled
Drug / intervention
Vitamin E +1 moredrug
Likely dose
Vitamin E 50 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193270
NCT01193270Phase 1Completed
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Single-Dose Vitamin E for Prevention of Mortality and Morbidity in Extremely Preterm Infants: Pilot Study

NICHD Neonatal Research Network·interventional·Posted Sep 1, 2010·Updated Nov 11, 2015

In Brief

A Phase 1 clinical trial evaluating Vitamin E and Placebo for Infant, Newborn and 4 related conditions. Completed, enrolled 93 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature, Intracranial Hemorrhages
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2010
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2011
TodayJul 1, 2026
Enrollment to primary: 10 monthsPosted 15.8 years ago

Interventions

Vitamin Edrug

A single intragastric dose of dl-α-tocopheryl acetate 50 IU/kg.

Placebodrug

Sterile water in volume equal to that of the comparator drug