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Completed

NCT Number: NCT00828451

Collaborative Research Group for Necrotizing Enterocolitis

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).

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 26, 2009
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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