At a glance
ClinicalIndex Comparison RecordN/ACompleted· 29 enrolled
Drug / intervention
[5,5,5-2H3]leucine (stable isotope labeled leucine)biological
Likely dose
[5,5,5-2H3]leucine (stable isotope labeled leucine) 1.8 mlfrom 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.
Collaborative Research Group for Necrotizing Enterocolitis
In Brief
A clinical study evaluating [5,5,5-2H3]leucine (stable isotope labeled leucine) for Prematurity and Necrotizing Enterocolitis. Completed, enrolled 29 participants across 1 site.
Detailed Summary
This proposal will test the hypothesis that synthesis and catabolism of epidermal growth factor (EGF), the genotype of the EGF gene, and the microbiome interact to influence EGF expression in infants at risk for necrotizing enterocolitis (NEC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity, Necrotizing Enterocolitis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJan 2009
Primary CompletionDec 2009
Study CompletionDec 2010
TodayJul 2026
First PostedJan 26, 2009
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago
Interventions
[5,5,5-2H3]leucine (stable isotope labeled leucine)biological
intravenous infusion of labeled leucine dissolved in 5% glucose water: priming dose of 18 micromoles (1.8 ml)/kg over 5 minutes, then 18 micromoles (1.8 ml)/hr for 6 hours; one infusion total