Collaborative Research Group for Necrotizing Enterocolitis



Status:Completed
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:May 2008
End Date:December 2010

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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).

- 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.

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
We found this trial at
1
site
Saint Louis, Missouri 63110
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Saint Louis, MO
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