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
|Condition or disease||Intervention/treatment||Phase|
|Prematurity Necrotizing Enterocolitis||Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine)||Not Applicable|
- 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|
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
- 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.
- 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.
- 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
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
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Aaron Hamvas, MD||Washington University School of Medicine|