Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-07 @ 11:03 PM
Study NCT ID:
NCT03208894
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2017-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Salbutamol and Furosemide in TTN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059245', 'term': 'Transient Tachypnea of the Newborn'}], 'ancestors': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-07-01', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of oxygen requiremment in neonates having TTN.', 'timeFrame': 'upto 6 months', 'description': 'neonates will be subjected to treatment with furosemide and sabutamol and the duration of oxygen dependecy will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transient Tachypnea of the Newborn']}, 'descriptionModule': {'briefSummary': 'to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all newborn babies with clinically diagnosed TTN\n\nExclusion Criteria:\n\n* babies less than 34 weeks babies with congenital malformations and CHD'}, 'identificationModule': {'nctId': 'NCT03208894', 'briefTitle': 'Role of Salbutamol and Furosemide in TTN', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Hospital, Pakistan'}, 'officialTitle': 'Role of Salbutamol and Furosemide in Transient Tachypnea of Newborn', 'orgStudyIdInfo': {'id': 'TTN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'with salbutamol', 'interventionNames': ['Drug: Furosemide Injection']}, {'type': 'EXPERIMENTAL', 'label': 'with furosemide', 'interventionNames': ['Drug: Furosemide Injection']}, {'type': 'EXPERIMENTAL', 'label': 'both furosemide and salbutamol', 'interventionNames': ['Drug: Furosemide Injection']}, {'type': 'NO_INTERVENTION', 'label': 'no inervention'}], 'interventions': [{'name': 'Furosemide Injection', 'type': 'DRUG', 'otherNames': ['salbutamol inhalation'], 'description': 'efficacy of salbutamol and furosemide in TTN', 'armGroupLabels': ['both furosemide and salbutamol', 'with furosemide', 'with salbutamol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Department of Pediatrics', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}, {'zip': '68000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Military Hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Hospital, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CONCULTANT PEDIATRICIAN', 'investigatorFullName': 'arshad khushdil', 'investigatorAffiliation': 'Armed Forces Hospital, Pakistan'}}}}