Collaborative Research Group for Necrotizing Enterocolitis

NCT00828451 | Completed Results DMC

• 1 other identifier: 08-0105
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Prematurity; Necrotizing Enterocolitis

Keywords

newborn; necrotizing enterocolitis; genetics; growth factors; metabolism

Outcome Measures

Primary Outcomes (2)

• Salivary EGF (Epidermal Growth Factor) Protein Levels

  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.

  Sampling occurred on average day of life 9 with a range from day of life 7 to 21

• Urinary EGF Protein Levels

  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.

  Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Secondary Outcomes (1)

• EGF Gene Sequencing

  Sampling occurred on average day of life 9 with a range from day of life 7 to 21

Study Arms (1)

Preterm Infants for EGF Profiles

EXPERIMENTAL

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)

Interventions

[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

Preterm Infants for EGF Profiles

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestation 32 weeks or less
• week of age or less
• intravenous line in place for clinical purposes

You may not qualify if:

• imminent death
• active infection
• pre-existing diagnosis of NEC
• fluid or electrolyte imbalance

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• 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. doi: 10.1053/j.semperi.2008.01.007.

  PMID: 18346534 BACKGROUND

• 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. doi: 10.1016/j.jpeds.2006.11.059.

  PMID: 17382110 BACKGROUND

• 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. doi: 10.1016/j.jpeds.2005.04.039.

  PMID: 16227034 BACKGROUND

• 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. doi: 10.1194/jlr.M400481-JLR200. Epub 2005 Mar 16.

  PMID: 15772427 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

stable isotope labeled EGF could not be detected in the urine and thus the project was closed

Results Point of Contact

• Title: Aaron Hamvas, MD
• Organization: Washington University

hamvas@kids.wustl.edu

314-454-6148

Study Officials

• Aaron Hamvas, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 26, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 4, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-03

Locations

US (1)