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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| EGF Gene Sequencing | Identification of computationally predicted functional variants in EGF gene | Sampling occurred on average day of life 9 with a range from day of life 7 to 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Hamvas, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18346534 | Background | 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. | |
| 17382110 | 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. |
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After enrollment 11 of 29 enrolled subjects did not complete the study due to removal of the intravenous line required for infusion, significant deterioration in clinical status resulting in unstable condition as identified by the attending physician, parental withdrawal, and death.
Subjects admitted to the neonatal intensive care unit at St. Louis Children's Hospital were screened and enrolled from 5/1/2008 to 12/31/2009. Infants born at < 32 weeks and 7 days old or less were eligible for enrollment which occurred in the neonatal intensive care unit or postpartum floor.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
29 subjects were enrolled. 11 subjects did not complete the study and were not analyzed due to lack of adequate specimens.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 29 subjects were enrolled with 11 not completing the study and not analyzed due to lack of specimens | Posted | Median | Full Range | picograms EGF/ microgram of protein | Sampling occurred on average day of life 9 with a range from day of life 7 to 21 |
|
20 months (5/1/2008 to 12/31/2009)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preterm Infants for EGF Profile | 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. |
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stable isotope labeled EGF could not be detected in the urine and thus the project was closed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Hamvas, MD | Washington University | 314-454-6148 | hamvas@kids.wustl.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 16227034 | 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. |
| 15772427 | 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. |
| Deterioration in clinical status |
|
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | 29 subjects were enrolled; 11 did not complete the study and were not analyzed | Posted | Median | Full Range | nanograms of EGF/mg of creatinine | Sampling occurred on average day of life 9 with a range from day of life 7 to 21 |
|
|
|
| Secondary | EGF Gene Sequencing | Identification of computationally predicted functional variants in EGF gene | 29 subjects were enrolled; 11 did not complete the study and were not analyzed | Posted | Number | percentage of participants with variant | Sampling occurred on average day of life 9 with a range from day of life 7 to 21 |
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|
|
| 1 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| D000091642 | Urogenital Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |