Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT01223261
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2010-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D007416', 'term': 'Intestinal Perforation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-14', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of conducting a randomized trial', 'timeFrame': '1 year', 'description': 'Ability to enroll infants in a 1-year period'}], 'secondaryOutcomes': [{'measure': 'Document variation in current surgical practices', 'timeFrame': 'Until hospital discharge or 120 days of life'}, {'measure': 'Prevalence of infants who would qualify for the study', 'timeFrame': 'Until hospital discharge or 120 days of life'}, {'measure': 'Frequency of postoperative complications', 'timeFrame': 'Until hospital discharge or 120 days of life'}, {'measure': 'Neurodevelopmental impairment', 'timeFrame': '18-22 months corrected age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NICHD Neonatal Research Network', 'Very Low Birth Weight (VLBW)', 'Extremely Low Birth Weight (ELBW)', 'Prematurity', 'Laparotomy', 'Drainage', 'Isolated intestinal perforation', 'Focal intestinal performation'], 'conditions': ['Infant, Newborn', 'Infant, Low Birth Weight', 'Infant, Small for Gestational Age', 'Infant, Premature', 'Enterocolitis, Necrotizing', 'Intestinal Perforation']}, 'referencesModule': {'references': [{'pmid': '15912048', 'type': 'RESULT', 'citation': 'Blakely ML, Lally KP, McDonald S, Brown RL, Barnhart DC, Ricketts RR, Thompson WR, Scherer LR, Klein MD, Letton RW, Chwals WJ, Touloukian RJ, Kurkchubasche AG, Skinner MA, Moss RL, Hilfiker ML; NEC Subcommittee of the NICHD Neonatal Research Network. Postoperative outcomes of extremely low birth-weight infants with necrotizing enterocolitis or isolated intestinal perforation: a prospective cohort study by the NICHD Neonatal Research Network. Ann Surg. 2005 Jun;241(6):984-9; discussion 989-94. doi: 10.1097/01.sla.0000164181.67862.7f.'}, {'pmid': '16549503', 'type': 'RESULT', 'citation': 'Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD; NICHD Neonatal Research Network. Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics. 2006 Apr;117(4):e680-7. doi: 10.1542/peds.2005-1273. Epub 2006 Mar 20.'}], 'seeAlsoLinks': [{'url': 'https://neonatal.rti.org/', 'label': 'NICHD Neonatal Research Network'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.', 'detailedDescription': 'Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely low birth weight (ELBW) infants. Isolated or focal intestinal perforation (IP) is a less common condition, affecting an estimated 4% of ELBWs, in which a hole develops in the intestines leaking fluid into the abdomin. The outcomes for infants with NEC or IP are poor: 49% die and half of the surviving infants are neurodevelopmentally impaired.\n\nSurgical options for NEC and IP include two possible procedures: peritoneal drainage, in which a tube is placed in the abdominal cavity through a small incision for fluid to drain out; or laparotomy, in which an incision is made in the abdomen and diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.\n\nThis study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.\n\nAll ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications.\n\nNeurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Extremely Low Birth Weight (ELBW) infants (those with birth weights \\<1000 g) born at participating NRN Centers diagnosed by a pediatric surgeon and neonatologist as having either necrotizing enterocolitis (NEC) or intestinal perforation (IP) requiring surgical intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database\n* Sage III NEC or isolated intestinal perforation\n* Pediatric surgeon decision to perform surgery for suspected NEC or IP\n\nExclusion Criteria:\n\n* Decision not to treat'}, 'identificationModule': {'nctId': 'NCT01223261', 'acronym': 'NEC Surgery', 'briefTitle': 'Observational Study of Surgical Treatment of Necrotizing Enterocolotis', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0027'}, 'secondaryIdInfos': [{'id': 'U10HD034216', 'link': 'https://reporter.nih.gov/quickSearch/U10HD034216', 'type': 'NIH'}, {'id': 'U10HD027904', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027904', 'type': 'NIH'}, {'id': 'U10HD021364', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021364', 'type': 'NIH'}, {'id': 'M01RR000080', 'link': 'https://reporter.nih.gov/quickSearch/M01RR000080', 'type': 'NIH'}, {'id': 'U10HD027853', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027853', 'type': 'NIH'}, {'id': 'M01RR008084', 'link': 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'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27157', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Case Western Reserve University, Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Women & Infants Hospital of Rhode 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Blakely, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Waldemar A. Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'William Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University, Women & Infants Hospital of Rhode Island'}, {'name': 'Avroy A. Fanaroff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case Western Reserve University, Rainbow Babies & Children's Hospital"}, {'name': 'Edward F. Donovan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Barbara J. Stoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Charles R. Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'James A. Lemons, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'David K. Stevenson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Abbot R. Laptook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}, {'name': 'Seetha Shankaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}, {'name': 'Richard A. Ehrenkranz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}, {'name': 'Ronald N. Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': "T. Michael O'Shea, MD MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University'}, {'name': 'Dale L. Phelps, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Neil N. Finer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'W. Kenneth Poole, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Martin L. Blakely, Lead Principal Investigator', 'oldOrganization': 'University of Texas Health Science Center at Houston'}}}}