Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 11:30 AM
Study NCT ID:
NCT00120159
Status:
UNKNOWN
Last Update Posted:
2008-01-15
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Necrotizing Enterocolitis (NEC) Surgical Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-07-07', 'lastUpdatePostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Necrotizing Enterocolitis'], 'conditions': ['Necrotizing Enterocolitis']}, 'descriptionModule': {'briefSummary': 'The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet at least one criterion from each of the following three categories:\n\nHistorical Factors:\n\n* Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile\n* Apneic/bradycardic episodes\n* Oxygen desaturation episode not otherwise explained\n* Guaiac positive or grossly bloody stools\n\nPhysical Examination Findings:\n\n* Abdominal distention recorded by practitioner\n* Capillary refill time greater than 2 seconds\n* Abdominal wall discoloration\n* Abdominal tenderness\n\nRadiographic Findings:\n\n* Pneumatosis intestinalis\n* Portal venous gas\n* Ileus\n* Dilated bowel\n* Pneumoperitoneum\n* Air/fluid levels\n* Thickened bowel walls\n* Ascites or peritoneal fluid\n* Free intraperitoneal air\n\nExclusion Criteria:\n\nPatients will be excluded for any of the following:\n\n* Major gastrointestinal anomaly\n* Prior abdominal operation\n* Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).'}, 'identificationModule': {'nctId': 'NCT00120159', 'briefTitle': 'Necrotizing Enterocolitis (NEC) Surgical Database', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol', 'orgStudyIdInfo': {'id': 'X03-12-080'}}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital, Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Tom Jaskic, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Glaser Pediatric Research Network', 'class': 'NETWORK'}, {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}]}}}