Ignite Creation Date:
2024-05-05 @ 9:09 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00828451
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2009-01-22
Brief Title:
Collaborative Research Group for Necrotizing Enterocolitis
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Collaborative Research Group for Necrotizing Enterocolitis
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Preterm infants will receive a six hour intravenous infusion of 555-2H3leucine 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 LCmass spectroscopy MSMS 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 mothers milk will be obtained for measurement of EGF after adequate volumes for infant feeds are achieved
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 LCmass spectroscopy MSMS 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 mothers milk will be obtained for measurement of EGF after adequate volumes for infant feeds are achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None