Collaborative Research Group for Necrotizing Enterocolitis

NCT ID: NCT00828451

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Preterm Infants for EGF Profiles

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Interventions

[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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Hamvas, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

St. Louis Children's Hospital

St Louis, Missouri, United States

Countries

United States

References

Nair RR, Warner BB, Warner BW. Role of epidermal growth factor and other growth factors in the prevention of necrotizing enterocolitis. Semin Perinatol. 2008 Apr;32(2):107-13. doi: 10.1053/j.semperi.2008.01.007.

Reference Type: BACKGROUND

PMID: 18346534 (View on PubMed)

Warner BB, Ryan AL, Seeger K, Leonard AC, Erwin CR, Warner BW. Ontogeny of salivary epidermal growth factor and necrotizing enterocolitis. J Pediatr. 2007 Apr;150(4):358-63. doi: 10.1016/j.jpeds.2006.11.059.

Reference Type: BACKGROUND

PMID: 17382110 (View on PubMed)

Spence KL, Zozobrado JC, Patterson BW, Hamvas A. Substrate utilization and kinetics of surfactant metabolism in evolving bronchopulmonary dysplasia. J Pediatr. 2005 Oct;147(4):480-5. doi: 10.1016/j.jpeds.2005.04.039.

Reference Type: BACKGROUND

PMID: 16227034 (View on PubMed)

Bohlin K, Patterson BW, Spence KL, Merchak A, Zozobrado JC, Zimmermann LJ, Carnielli VP, Hamvas A. Metabolic kinetics of pulmonary surfactant in newborn infants using endogenous stable isotope techniques. J Lipid Res. 2005 Jun;46(6):1257-65. doi: 10.1194/jlr.M400481-JLR200. Epub 2005 Mar 16.

Reference Type: BACKGROUND

PMID: 15772427 (View on PubMed)

Other Identifiers

08-0105

Identifier Type: -

Identifier Source: org_study_id