Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT06267118
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-02-18', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wood-Downes-Ferres clinical score calculation', 'timeFrame': 'at 24 and 48 hours of treatment', 'description': 'A score of 0-3 mild, 4-6 moderately ill, \\>6 severely ill'}], 'secondaryOutcomes': [{'measure': 'total length of hospitalization', 'timeFrame': 'less than 7 days, 7-10 days, 10-14 days', 'description': 'less than 1 week, more than 1 week,'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wood-Downes Clinical scoring System'], 'conditions': ['Acute Bronchiolitis Due to Respiratory Syncytial Virus']}, 'referencesModule': {'references': [{'pmid': '25452661', 'type': 'RESULT', 'citation': 'Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014 Dec;35(12):519-30. doi: 10.1542/pir.35-12-519. No abstract available.'}, {'pmid': '19953579', 'type': 'RESULT', 'citation': 'Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.'}, {'pmid': '27549684', 'type': 'RESULT', 'citation': 'Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017 Jan 14;389(10065):211-224. doi: 10.1016/S0140-6736(16)30951-5. Epub 2016 Aug 20.'}, {'pmid': '19884591', 'type': 'RESULT', 'citation': 'Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.'}, {'pmid': '29265171', 'type': 'RESULT', 'citation': 'Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD006458. doi: 10.1002/14651858.CD006458.pub4.'}, {'pmid': '12675760', 'type': 'RESULT', 'citation': 'Hariprakash S, Alexander J, Carroll W, Ramesh P, Randell T, Turnbull F, Lenney W. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis. Pediatr Allergy Immunol. 2003 Apr;14(2):134-9. doi: 10.1034/j.1399-3038.2003.00014.x.'}, {'pmid': '28470580', 'type': 'RESULT', 'citation': 'Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4.'}], 'seeAlsoLinks': [{'url': 'https://www.ijpediatrics.com/index.php/ijcp/article/view/4218', 'label': 'RCTnebulized epinephrine versus nebulized hypertonic saline in infants with acute bronchiolitis'}, {'url': 'http://doi.org/10.1016/j.earlhumdev.2013.07.016', 'label': 'Viral bronchiolitis in children: A common condition with few therapeutic options'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients\n\n1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis\n2. Length of Hospitalization', 'detailedDescription': 'This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children admitted in PICU with acute bronchiolitis\n\nExclusion Criteria:\n\n* children with co-exiting illnesses like\n\n 1. Congenital Heart Disease\n 2. Immunodeficiency\n 3. other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH\n 4. Kidneys or liver problem\n 5. Seizures'}, 'identificationModule': {'nctId': 'NCT06267118', 'acronym': 'children', 'briefTitle': 'Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital, Pakistan'}, 'officialTitle': 'A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children', 'orgStudyIdInfo': {'id': 'Treatment of Bronchiolitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertonic saline nebulization group', 'description': 'First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa', 'interventionNames': ['Drug: Hypertonic Saline Solution, 1 Ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adrenaline nebulization group', 'description': 'Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa', 'interventionNames': ['Drug: Adrenaline']}], 'interventions': [{'name': 'Hypertonic Saline Solution, 1 Ml', 'type': 'DRUG', 'otherNames': ['Drug A'], 'description': 'Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization', 'armGroupLabels': ['Hypertonic saline nebulization group']}, {'name': 'Adrenaline', 'type': 'DRUG', 'otherNames': ['Drug B'], 'description': 'dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization', 'armGroupLabels': ['Adrenaline nebulization group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24110', 'city': 'Nowshera', 'state': 'KPK', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Syed Qamar Zaman', 'role': 'CONTACT', 'email': 'dr.qamarzaman@hotmail.com', 'phone': '00923365307823'}, {'name': 'Shahid Mahmud', 'role': 'CONTACT', 'email': 'childspec@hotmail.com', 'phone': '00923315301289'}, {'name': 'Syed Qamar Zaman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Combined Military Hospital', 'geoPoint': {'lat': 29.16614, 'lon': 71.87718}}], 'centralContacts': [{'name': 'Syed Qamar Zaman', 'role': 'CONTACT', 'email': 'dr.qamarzaman@hotmail.com', 'phone': '00923365307823'}, {'name': 'Madeeha Qamar', 'role': 'CONTACT', 'email': 'affifamadhu89@gmail.com', 'phone': '00923353459662'}], 'overallOfficials': [{'name': 'Prof Shahid Mahmud', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Military Hospital Rawalpindi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After informed consent of participants and ethical committee approval, it will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Combined Military Hospital, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor & Head of Pediatrics Department', 'investigatorFullName': 'Syed Qamar Zaman', 'investigatorAffiliation': 'Combined Military Hospital, Pakistan'}}}}