Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02691858
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007443', 'term': 'Intussusception'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'C007133', 'term': 'hydrocortisone hemisuccinate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of Pneumatic Reduction', 'timeFrame': '1 Hour', 'description': 'Comparing number of Successful Pneumatic Reductions in both groups'}], 'secondaryOutcomes': [{'measure': 'Reducing number of trials of Pneumatic Reduction', 'timeFrame': '2 Hours', 'description': 'Comparing average number of Pneumatic Reduction trials between both groups'}, {'measure': 'Reducing complications', 'timeFrame': '2 Hours', 'description': 'Comparing number of complications in both groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intussusception'], 'conditions': ['Intussusception']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gersema, Lisa, and Karen Baker.'}, {'type': 'RESULT', 'citation': 'Kara, Cüneyt Orhan, and Inci Gökalan.'}]}, 'descriptionModule': {'briefSummary': 'Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.\n\nOur surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.', 'detailedDescription': 'Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.\n\nControl group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infantile Intussusception\n\nExclusion Criteria:\n\n* Peritonitis Pneumoperitoneum Morbid patients'}, 'identificationModule': {'nctId': 'NCT02691858', 'briefTitle': 'Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAIUNIPEDSURG-CR3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrocortisone', 'description': 'Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction', 'interventionNames': ['Drug: Hydrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'otherNames': ['Solu-Cortef'], 'description': '10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction', 'armGroupLabels': ['Hydrocortisone']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['sodium chloride 0.9%'], 'description': '100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud Elfiky, MD', 'role': 'CONTACT', 'email': 'mfiky@kasralainy.edu.eg'}, {'name': 'Mostafa Gad, MD', 'role': 'CONTACT', 'email': 'mostafagad@kasralainy.edu.eg'}, {'name': 'Mostafa Gad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University Pediatric Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mostafa Gad, MSc', 'role': 'CONTACT', 'email': 'mostafagad@kasralainy.edu.eg', 'phone': '201002265009'}, {'name': 'Mahmoud Elfiky, MD', 'role': 'CONTACT', 'email': 'mfiky@kasralainy.edu.eg', 'phone': '201001557755'}], 'overallOfficials': [{'name': 'Gamal El Tagy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatric Surgery', 'investigatorFullName': 'Mahmoud El Fiky', 'investigatorAffiliation': 'Cairo University'}}}}