Collaborative Research Group for Necrotizing Enterocolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00828451
First received: January 22, 2009
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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: 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 ] [ Designated as safety issue: No ]
  • EGF genotype [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • composition of the microbiome [ Time Frame: weekly from birth to 6 weeks of age ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828451

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

Publications:
Responsible Party: Aaron Hamvas, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00828451     History of Changes
Other Study ID Numbers: 08-0105
Study First Received: January 22, 2009
Last Updated: December 17, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014