NCT00828451

Collaborative Research Group for Necrotizing Enterocolitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Not accepted

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).

Detailed description

* Preterm infants will receive a six hour intravenous infusion of \[5,5,5-2H3\]leucine (2H3) 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 liquid chromatography (LC)/mass spectroscopy (MS)/MS technology, as well as enzyme-linked immunosorbent assay (ELISA) . 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.

Conditions

• Prematurity
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
BIOLOGICAL	[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

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2009-01-26
• Last updated: 2018-04-04
• Results posted: 2018-03-07

Locations

1 site across 1 country: United States