Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-31 @ 10:38 AM
Study NCT ID:
NCT00539292
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2007-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020139', 'term': 'Gastroschisis'}], 'ancestors': [{'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jacob.langer@sickkids.ca', 'phone': '416-813-7340', 'title': 'Dr Jacob C Langer', 'organization': 'The Hospital for Sick Children'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Difficulty with patient enrollment because of parent refusal or absence for consent and individual surgeon preference not to randomize patients; this limited the number of patients enrolled and prevented adequate statistical power to be achieved.'}}, 'adverseEventsModule': {'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)', 'eventGroups': [{'id': 'EG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 2, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 1, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atresia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Short Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ventilation Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'OG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure (measured in days)', 'description': 'length of time on the ventilator', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'OG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraabdominal pressure at the time of definitive closure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of lAP at the time of abdominal wall closure was subject to adjustment as the data measured by intragastric catheter were only available for 15 patients in the spring-loaded silo group and 19 patients in the primary closure group.'}, {'type': 'SECONDARY', 'title': 'TPN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'OG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '33', 'groupId': 'OG000'}, {'value': '33', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)', 'description': 'use of total parenteral nutrition (TPN)', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'OG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '34', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.', 'description': 'days in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications During Hospitalization (e.g., Sepsis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'OG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.', 'description': 'Clinical sepsis confirmed with a positive blood culture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'FG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method.\n\n27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 195 infants with gastroschisis were admitted to the participating centers between June 2001 and December 2006. After screening for eligibility and obtaining consent for enrollment, 55 patients were randomized. A randomization plan was generated by the lead center through an electronic Web-based randomization program.', 'preAssignmentDetails': '55 patients were randomized, 28 infants in the spring-loaded silo group and 27 infants in the primary closure group. One patient in the spring-loaded silo group was excluded from the study because of repeated dislodg-ement of the silo, requiring use of a sewn prosthetic device and inability to perform secondary closure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Silastic Spring-Loaded Silo Group', 'description': 'Silastic Spring-Loaded Silo Group\n\nPrimary placement of a spring-loaded silo\n\nSilastic Spring-Loaded Silo Group - Primary placement of a spring-loaded silo: routine bedside placement of a preformed Silastic spring-loaded silo, with gradual reduction and elective abdominal wall closure.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method. 28 Infants had a spring-loaded silo placed in the delivery room or the neonatal intensive care unit. Reduction of the eviscerated bowel was accomplished by the daily application of gentle pressure, followed by the placement of a clip or umbilical tape across the silo to maintain the reduction. When the bowel was completely reduced, a clinical decision was made by the responsible surgeon for either silo removal and abdominal wall closure in the operating room under general anesthesia or abdominal wall closure at the bedside using the umbilical flap technique.'}, {'id': 'BG001', 'title': 'Primary Closure of Abdomen Group', 'description': 'Primary Closure of Abdomen Group\n\nPrimary Closure: primary closure of abdomen\n\nPrimary Closure of Abdomen Group - Primary Closure: primary closure of abdomen: immediate attempt at primary closure, with placement of a silo only if primary closure was unsuccessful.\n\nPatients were assigned to 1 of the 2 groups using the sealed-envelope method. 27 Infants underwent an attempt at primary closure. These infants underwent complete bowel reduction and abdominal wall closure, either in the operating room under general anesthesia or at the bedside. If the operating surgeon believed that primary closure would result in excessive lAP, a clinical decision was made to delay abdominal wall closure, and a spring-loaded silo was applied for gradual reduction and subsequent closure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational age (wk)', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight (g)', 'classes': [{'categories': [{'measurements': [{'value': '2446', 'spread': '567', 'groupId': 'BG000'}, {'value': '2382', 'spread': '391', 'groupId': 'BG001'}, {'value': '2414', 'spread': '479', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The study was terminated in December 2006 (despite not achieving the initial target of 88 patients), the existing rate of patient accrual, would take an extensive amount of time to enter a planned number of patients; and during this period, other changes in perioperative management of surgical neonates may invalidate the study comparisons.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'whyStopped': 'With the existing rate of patient accrual, it would take an extensive amount of time to reach the initial target of 88 patients. During this period, other changes in perioperative management of surgical neonates may invalidate the study comparisons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2007-10-02', 'resultsFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2007-10-02', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-12', 'studyFirstPostDateStruct': {'date': '2007-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation Status', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure (measured in days)', 'description': 'length of time on the ventilator'}], 'secondaryOutcomes': [{'measure': 'Intraabdominal Pressure (IAP) as Reflected by Intragastric Pressure', 'timeFrame': 'intraabdominal pressure at the time of definitive closure'}, {'measure': 'TPN', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure, then monthly for 3 months until discharge (measured in days)', 'description': 'use of total parenteral nutrition (TPN)'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.', 'description': 'days in hospital'}, {'measure': 'Complications During Hospitalization (e.g., Sepsis)', 'timeFrame': 'post-surgery to hospital discharge; Data collected daily during the first 14 days after the abdominal wall closure (measured in days), then monthly for 3 months until discharge.', 'description': 'Clinical sepsis confirmed with a positive blood culture'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatrics', 'gastroschisis', 'silastic spring-loaded silo'], 'conditions': ['Gastroschisis']}, 'referencesModule': {'references': [{'pmid': '18926212', 'type': 'RESULT', 'citation': 'Pastor AC, Phillips JD, Fenton SJ, Meyers RL, Lamm AW, Raval MV, Lehman E, Karp TB, Wales PW, Langer JC. Routine use of a SILASTIC spring-loaded silo for infants with gastroschisis: a multicenter randomized controlled trial. J Pediatr Surg. 2008 Oct;43(10):1807-12. doi: 10.1016/j.jpedsurg.2008.04.003.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate whether the routine, primary use of the spring-loaded silo (SLS) to treat infants with gastroschisis will result in improved outcomes, faster recovery times and fewer post-surgical complications than the standard selective use of the silo.', 'detailedDescription': 'Standard treatment of the infant with gastroschisis consists of , the bowel being reduced into the abdomen, when possible,and the abdominal wall defect being closed in the operating room. When complete reduction of the eviscerated contents is not possible, a silastic " silo" is sewn on the abdominal wall and its contents are gradually reduced into the abdomen over several days. Once reduction is obtained, the silo is removed and the abdominal defect is closed.\n\nCurrent methods of treatment are associated with significant morbidity, prolonged hospitalization, and high costs. Gastroschisis closure continues to be accompanied by a number of complications ranging from ileus, sepsis, TPN-related liver damage, necrotizing enterocolitis, respiratory insufficiency, and death. The optimal timing and method of closure, including primary versus secondary closure, continues to be debated. No prospective randomized studies to date have examined the routine use of the spring-loaded silo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Gastroschisis\n* Birth Weight ≥ 1500 grams\n* Gestational Age ≥ 34 weeks\n\nExclusion Criteria:\n\n* Birth Weight \\< 1500 grams\n* Gestational Age \\< 34 weeks\n* Presence of Bowel Ischemia or Necrosis\n* Abdominal wall defect too small\n* Major associated anomalies or medical condition\n* Presence of Intracranial Hemorrhage (grade IV)\n* Parent Refusal for Randomization'}, 'identificationModule': {'nctId': 'NCT00539292', 'briefTitle': 'Evaluating the Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'A Multi-Centre, Prospective Randomized Trial to Evaluate Routine Use of a Silastic Spring-Loaded Silo for Infants With Gastroschisis', 'orgStudyIdInfo': {'id': '0020010078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Silastic Spring-Loaded Silo', 'interventionNames': ['Procedure: Primary placement of a spring-loaded silo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Primary Closure of Abdomen', 'interventionNames': ['Procedure: Primary Closure']}], 'interventions': [{'name': 'Primary placement of a spring-loaded silo', 'type': 'PROCEDURE', 'armGroupLabels': ['1']}, {'name': 'Primary Closure', 'type': 'PROCEDURE', 'description': 'primary closure of abdomen', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jacob Langer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children, Toronto Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Surgeon', 'investigatorFullName': 'Jacob Langer', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}