Hypertonic Saline Inhalation in Acute Bronchiolitis
A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedFebruary 11, 2020
March 1, 2019
8 months
March 17, 2019
February 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Hospital length of stay
time taken to discharge or ready to be discharged
24 hours
Study Arms (3)
normal saline with bronchdilator
EXPERIMENTALwill recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours
hypertonic saline with bronchodilator
EXPERIMENTALwill recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours
hypertonic saline only
EXPERIMENTALwill recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours
Interventions
patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours
patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours
patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours
Eligibility Criteria
You may qualify if:
- infants less than 24 months of age with adiagnosis of acute bronchiolitis
You may not qualify if:
- other infants and children above 24 months of age
- patients with other diseases than acute bronchiolitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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: 24093893RESULTSmyth RL, Openshaw PJ. Bronchiolitis. Lancet. 2006 Jul 22;368(9532):312-22. doi: 10.1016/S0140-6736(06)69077-6.
PMID: 16860701RESULTRudan 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: 15654403RESULTZorc 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.
PMID: 20100768RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 17, 2019
First Posted
March 19, 2019
Study Start
July 20, 2020
Primary Completion
March 20, 2021
Study Completion
September 20, 2021
Last Updated
February 11, 2020
Record last verified: 2019-03