Clinical Trial: Collaborative Research Group for Necrotizing Enterocolitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Collaborative Research Group for Necrotizing Enterocolitis

Brief Summary: 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).

Detailed Summary:

  • 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.

Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Washington University School of Medicine

Dates:
Date Received: January 22, 2009
Date Started: May 2008
Date Completion: December 2010
Last Updated: December 17, 2009
Last Verified: December 2009