Collaborative Research Group for Necrotizing Enterocolitis

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00828451
Study type	Interventional
Source	Washington University School of Medicine
Contact
Status	Completed
Phase	N/A
Start date	May 2008
Completion date	December 2010

View Details

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