Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00828451
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Collaborative Research Group for Necrotizing Enterocolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hamvas@kids.wustl.edu', 'phone': '314-454-6148', 'title': 'Aaron Hamvas, MD', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'stable isotope labeled EGF could not be detected in the urine and thus the project was closed'}}, 'adverseEventsModule': {'timeFrame': '20 months (5/1/2008 to 12/31/2009)', 'eventGroups': [{'id': 'EG000', 'title': 'Preterm Infants for EGF Profile', 'description': '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.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Salivary EGF (Epidermal Growth Factor) Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Infants for EGF Profiles', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': '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.', 'unitOfMeasure': 'picograms EGF/ microgram of protein', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were enrolled with 11 not completing the study and not analyzed due to lack of specimens'}, {'type': 'PRIMARY', 'title': 'Urinary EGF Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Infants for EGF Profiles', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '146'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': '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.', 'unitOfMeasure': 'nanograms of EGF/mg of creatinine', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were enrolled; 11 did not complete the study and were not analyzed'}, {'type': 'SECONDARY', 'title': 'EGF Gene Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Infants for EGF Profiles', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': 'Identification of computationally predicted functional variants in EGF gene', 'unitOfMeasure': 'percentage of participants with variant', 'reportingStatus': 'POSTED', 'populationDescription': '29 subjects were enrolled; 11 did not complete the study and were not analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preterm Infants for EGF Profiles', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of intravenous line', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Deterioration in clinical status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Preterm Infants for EGF Profiles', 'description': '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '29 subjects were enrolled. 11 subjects did not complete the study and were not analyzed due to lack of adequate specimens.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2009-01-22', 'resultsFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-07', 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary EGF (Epidermal Growth Factor) Protein Levels', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': '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.'}, {'measure': 'Urinary EGF Protein Levels', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'EGF Gene Sequencing', 'timeFrame': 'Sampling occurred on average day of life 9 with a range from day of life 7 to 21', 'description': 'Identification of computationally predicted functional variants in EGF gene'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['newborn', 'necrotizing enterocolitis', 'genetics', 'growth factors', 'metabolism'], 'conditions': ['Prematurity', 'Necrotizing Enterocolitis']}, 'referencesModule': {'references': [{'pmid': '18346534', 'type': 'BACKGROUND', 'citation': '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': '17382110', 'type': 'BACKGROUND', 'citation': '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': '16227034', 'type': 'BACKGROUND', 'citation': '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': '15772427', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "* 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.\n* 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.\n* 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.\n* Stool will be obtained every 3 to 7 days through 5 weeks to evaluate inflammatory markers and the microbiome.\n* If breastfeeding, a single sample of mother's milk will be obtained for measurement of EGF after adequate volumes for infant feeds are achieved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestation 32 weeks or less\n* 1 week of age or less\n* intravenous line in place for clinical purposes\n\nExclusion Criteria:\n\n* imminent death\n* active infection\n* pre-existing diagnosis of NEC\n* fluid or electrolyte imbalance'}, 'identificationModule': {'nctId': 'NCT00828451', 'briefTitle': 'Collaborative Research Group for Necrotizing Enterocolitis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Collaborative Research Group for Necrotizing Enterocolitis', 'orgStudyIdInfo': {'id': '08-0105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preterm Infants for EGF Profiles', 'description': '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.', 'interventionNames': ['Biological: [5,5,5-2H3]leucine (stable isotope labeled leucine)']}], 'interventions': [{'name': '[5,5,5-2H3]leucine (stable isotope labeled leucine)', 'type': 'BIOLOGICAL', 'description': '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', 'armGroupLabels': ['Preterm Infants for EGF Profiles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Aaron Hamvas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}