This trial is active, not recruiting.

Conditions prematurity, necrotizing enterocolitis
Treatment [5,5,5-2h3]leucine (stable isotope labeled leucine)
Sponsor Washington University School of Medicine
Start date May 2008
End date December 2009
Trial size 48 participants
Trial identifier NCT00828451, 08-0105


This proposal will test the hypothesis that synthesis and catabolism of epidermal growth factor, the genotype of the EGF gene, and the microbiome interact to influence EGF expression in infants at risk for necrotizing enterocolitis (NEC).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Premature infants born at < 32 weeks gestation who are 7 days old or less.
[5,5,5-2h3]leucine (stable isotope labeled leucine)
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

Primary Outcomes

rate of EGF synthesis and catabolism
time frame: 1 week of age
EGF genotype
time frame: 1 week of age
composition of the microbiome
time frame: weekly from birth to 6 weeks of age

Eligibility Criteria

Male or female participants up to 7 days old.

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

Additional Information

Official title Collaborative Research Group for Necrotizing Enterocolitis
Principal investigator Aaron Hamvas, MD
Description - Preterm infants will receive a six hour intravenous infusion of [5,5,5-2H3]leucine through an existing intravenous line (IV) to measure EGF synthesis rate. - Two blood samples will be obtained, one prior to the start of infusion, and one during the infusion. The enrichment of the stable isotope labeled leucine will be measured in the plasma from these samples; DNA will be extracted from the residual cell pellets. The EGF and EGF receptor genes will be sequenced. - Saliva and urine will be obtained for 5 days following infusion to measure EGF and the rate of incorporation of leucine into EGF using LC/MS/MS technology. Saliva will be obtained by a Q tip swab and urine and stool obtained from the diaper. - Stool will be obtained every 3 to 7 days through 5 weeks to evaluate inflammatory markers and the microbiome. - If breastfeeding, a single sample of mother's milk will be obtained for measurement of EGF after adequate volumes for infant feeds are achieved.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.