Collaborative Research Group for Necrotizing Enterocolitis

The Washington University

Status: Completed

Conditions: Prematurity; Necrotizing Enterocolitis

Treatments: Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine)

Study type: Interventional

Funder types: Other

Identifiers

NCT00828451

08-0105

Details and patient eligibility

About

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).

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Preterm Infants for EGF Profiles

Experimental group

Description:

Premature infants born at \< 32 weeks gestation who are 7 days old or less. Infants received and intravenous infusion of \[5,5,5-2H3\]leucine (stable isotope labeled leucine) with sampling of blood, urine and saliva.

Treatment:

Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine)