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Collaborative Research Group for Necrotizing Enterocolitis

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ClinicalTrials.gov Identifier: NCT00828451
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : March 7, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Prematurity Necrotizing Enterocolitis Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Collaborative Research Group for Necrotizing Enterocolitis
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
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



Primary Outcome Measures :
  1. Salivary EGF (Epidermal Growth Factor) Protein Levels [ Time Frame: Sampling occurred on average day of life 9 with a range from day of life 7 to 21 ]
    Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.

  2. Urinary EGF Protein Levels [ Time Frame: Sampling occurred on average day of life 9 with a range from day of life 7 to 21 ]
    Urinary EGF protein levels obtained from free flowing urine samples retrieved from subject diaper were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to milligrams of creatinine in urine, and expressed as nanograms of EGF protein per milligram of urinary creatinine.


Secondary Outcome Measures :
  1. EGF Gene Sequencing [ Time Frame: Sampling occurred on average day of life 9 with a range from day of life 7 to 21 ]
    Identification of computationally predicted functional variants in EGF gene



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828451


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