Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT03880903
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2019-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertonic Saline Inhalation in Acute Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic 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': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-09', 'studyFirstSubmitDate': '2019-03-17', 'studyFirstSubmitQcDate': '2019-03-17', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '24 hours', 'description': 'time taken to discharge or ready to be discharged'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '24093893', 'type': 'RESULT', 'citation': 'Teshome G, Gattu R, Brown R. Acute bronchiolitis. Pediatr Clin North Am. 2013 Oct;60(5):1019-34. doi: 10.1016/j.pcl.2013.06.005. Epub 2013 Jul 24.'}, {'pmid': '16860701', 'type': 'RESULT', 'citation': 'Smyth RL, Openshaw PJ. Bronchiolitis. Lancet. 2006 Jul 22;368(9532):312-22. doi: 10.1016/S0140-6736(06)69077-6.'}, {'pmid': '15654403', 'type': 'RESULT', 'citation': 'Rudan I, Tomaskovic L, Boschi-Pinto C, Campbell H; WHO Child Health Epidemiology Reference Group. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bull World Health Organ. 2004 Dec;82(12):895-903. Epub 2005 Jan 5.'}, {'pmid': '20100768', 'type': 'RESULT', 'citation': 'Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection', 'detailedDescription': 'Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection. Bronchiolitis is a significant cause of respiratory disease worldwide. according to the World Health Organization bullet in, an estimated 150 million new cases occur annually; 11-20 million (7-13%) of these cases are severe enough to require hospital admission. Worldwide, 95% of all cases occur in developing countries. Typically, initial clinical manifestations include upper respiratory tract symptoms such as cough, nasal congestion, and low-grade fever lasting 1 to 3 days, followed by expiratory wheezing, nasal flaring, fine crackles, oxygen saturation on presentation\\<94%, tachypnea, increased work of breathing, use of accessory muscles, and retractions in some patients. The need for hospitalization depends on the presence of respiratory symptoms (degree of retractions, increased respiratory effort, decreased oxygen saturation), cyanosis, restlessness or lethargy, and underlying disease states, including apnea. Since no definitive antiviral therapy exists for most causes of bronchiolitis, management of these infants should be directed toward symptomatic relief and maintenance of hydration and oxygenation. One medication that has demonstrated promising results in the management of acute bronchiolitis is nebulized hypertonic saline , Its hyperosmolarity helps to absorb water from the mucosal and submucosal space, thereby increasing mucociliary function by clearing fluids accumulated in the airway and mucus plugs in the lungs. Hypertonic saline can also induce cough to help enhance mucus clearance. The American Academy Of Pediatrics guidelines recommend administration of hypertonic saline in hospitalized bronchiolitis patients. The most common dosage studied is hypertonic saline 3% 4 mL per dose inhaled by nebulizer every 4 to 6 hours, which may take ≥24 hours to work and is typically continued while the child is hospitalized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants less than 24 months of age with adiagnosis of acute bronchiolitis\n\nExclusion Criteria:\n\n* other infants and children above 24 months of age\n* patients with other diseases than acute bronchiolitis'}, 'identificationModule': {'nctId': 'NCT03880903', 'briefTitle': 'Hypertonic Saline Inhalation in Acute Bronchiolitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children', 'orgStudyIdInfo': {'id': 'HS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'normal saline with bronchdilator', 'description': 'will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours', 'interventionNames': ['Drug: normal saline and salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'hypertonic saline with bronchodilator', 'description': 'will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours', 'interventionNames': ['Drug: hypertonic saline and salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'hypertonic saline only', 'description': 'will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours', 'interventionNames': ['Drug: Hypertonic saline']}], 'interventions': [{'name': 'normal saline and salbutamol', 'type': 'DRUG', 'description': 'patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours', 'armGroupLabels': ['normal saline with bronchdilator']}, {'name': 'hypertonic saline and salbutamol', 'type': 'DRUG', 'description': 'patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours', 'armGroupLabels': ['hypertonic saline with bronchodilator']}, {'name': 'Hypertonic saline', 'type': 'DRUG', 'description': 'patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours', 'armGroupLabels': ['hypertonic saline only']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mohamed El Tellawy, professor', 'role': 'CONTACT', 'email': 'mohamed.mohamed51@med.au.eg', 'phone': '00201003486595'}, {'name': 'Duaa Raafat, Assis prof', 'role': 'CONTACT', 'email': 'doaa.ahmed3@med.au.eg', 'phone': '00201223112124'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'MASamoael', 'investigatorAffiliation': 'Assiut University'}}}}