N/A
N=29
Collaborative Research Group for Necrotizing Enterocolitis
Prematurity · Necrotizing Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT00828451 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Salivary EGF (Epidermal Growth Factor) Protein Levels — 15 picograms EGF/ microgram of protein
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- [5,5,5-2H3]leucine (stable isotope labeled leucine) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary EGF (Epidermal Growth Factor) Protein Levels |
15 | — |
| PRIMARY Urinary EGF Protein Levels |
48 | — |
| SECONDARY EGF Gene Sequencing |
11 | — |
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).
Eligibility Criteria
Inclusion Criteria
- gestation 32 weeks or less
- 1 week of age or less
- intravenous line in place for clinical purposes
Exclusion Criteria
- imminent death
- active infection
- pre-existing diagnosis of NEC
- fluid or electrolyte imbalance
Data sourced from ClinicalTrials.gov (NCT00828451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.