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

History of Changes

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:

Drug Information available for: Leucine

U.S. FDA Resources

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

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 School of Medicine

More Information

Publications:

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. Review.

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.

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.

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. Epub 2005 Mar 16.

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 June 18, 2013

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