Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:49 PM
Study NCT ID:
NCT06862895
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2025-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Clinical Outcomes of Infants with Bronchiolitis', 'timeFrame': 'baseline', 'description': 'changing of oxygen saturation( SPO2) \\<90% to normal level SPO2\\>92%'}, {'measure': 'change in physiological outcomes of Infants with Bronchiolitis', 'timeFrame': 'baseline', 'description': 'change in respiratory rate from abnormal to normal (0-3 month RR:35-55 3-6 month RR:30-45 6-12 month RR:25-40) breath per minute'}], 'secondaryOutcomes': [{'measure': "Improvement in Knowledge of Mother's", 'timeFrame': 'After 3 days', 'description': "after application of educational program expected to to improve mother's knowledge regarding chest physiotherapy"}, {'measure': "Improvement in practices of Mother's", 'timeFrame': 'After 3 days', 'description': "after application of educational program expected to to improve mother's practice regarding chest physiotherapy"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiolitis', 'Infant, Newborn, Diseases', 'Chest Physiotherapy', 'Educational Program']}, 'descriptionModule': {'briefSummary': "The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician\n\nThe main questions aims to answer:\n\n* Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?\n* Does educational program improve mothers knowledge and practice regarding chest physiotherapy?\n\nResearcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.\n\nExclusion Criteria:\n\n1. Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)\n2. Children who intubated and admitted to Intensive Care Unit (ICU).'}, 'identificationModule': {'nctId': 'NCT06862895', 'briefTitle': 'Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': "Effect of Chest Physiotherapy Educational Program on Mother's Knowledge, Practice and Clinical Outcomes of Infants With Bronchiolitis", 'orgStudyIdInfo': {'id': 'CPT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'chest physiotherapy', 'interventionNames': ['Other: chest physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention'}], 'interventions': [{'name': 'chest physiotherapy', 'type': 'OTHER', 'description': 'Chest Physiotherapy is including various techniques, in this study classical CPT was used to be applied to participants', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61002', 'city': 'Erbil', 'state': 'Kurdistan', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Nazar R Othman, Assist.Prof', 'role': 'CONTACT', 'email': 'nazar.othman@hmu.edu.krd', 'phone': '750 494 6398', 'phoneExt': '+964'}], 'facility': 'Hawler Medical University', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}], 'centralContacts': [{'name': 'Nazar Othman, Assist.Prof', 'role': 'CONTACT', 'email': 'nazar.othman@hmu.edu.krd', 'phone': '750 494 6398', 'phoneExt': '+964'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal Investigator', 'investigatorFullName': 'Shaimaa Shwan', 'investigatorAffiliation': 'Hawler Medical University'}}}}