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Collaborative Research Group for Necrotizing Enterocolitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
Information provided by:
Washington University School of Medicine Identifier:
First received: January 22, 2009
Last updated: December 17, 2009
Last verified: December 2009
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).

Condition Intervention
Prematurity Necrotizing Enterocolitis Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Collaborative Research Group for Necrotizing Enterocolitis

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: May 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEC study
Premature infants born at < 32 weeks gestation who are 7 days old or less.
Biological: [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

Detailed Description:
  • 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.

Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00828451

United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Aaron Hamvas, MD Washington University School of Medicine
  More Information

Responsible Party: Aaron Hamvas, MD, Washington University School of Medicine Identifier: NCT00828451     History of Changes
Other Study ID Numbers: 08-0105
Study First Received: January 22, 2009
Last Updated: December 17, 2009

Keywords provided by Washington University School of Medicine:
necrotizing enterocolitis
growth factors

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on September 19, 2017