Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.
Interventional Study: Hypertonic Saline as Add on Treatment to the Usual Therapy for Preschool Children With Acute "Asthmatic" Attack Presenting to the ER: A Double Blind Control Study
1 other identifier
interventional
41
1 country
1
Brief Summary
To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year old children with "asthmatic" attack presenting to Emergency Department (ED). Background: In 1-6 year old children, the most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children are not atopic and often do not respond very well to bronchodilators and steroids. Thus novel treatments are needed. HS is considered an effective and safe treatment for infants with acute viral bronchiolitis (Cochrane 2008). HS acts in the airways in several mechanisms: HS re-hydrates secretions and improving mucus rheology, reduce edema of the airway wall by absorbing water from the mucosa and submucosa, causes sputum induction and cough, which can help to clear the sputum out of the bronchi, stimulates cilial beat via the release of prostaglandin E2, breaks the ionic bonds within the mucus gel, thereby lowering the viscosity and elasticity of the mucus secretion. It is estimated that all the above HS responding elements may play a role in this viral induce wheezing. The above mentioned theoretical benefits provide the rationale for the possible treatment of viral induced acute wheezing ("asthma") attack with nebulized HS in young pre-school children presenting to the Pediatric Emergency Unit with acute (mostly viral induced) wheezing. Therefore, the purpose of the present study is to 1. Investigate the addition of frequently nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes presenting to the emergency department (ED) in preschool children in a prospective, randomized, double-blind, controlled fashion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Jan 2009
Typical duration for not_applicable asthma
1 active site
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
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 9, 2011
August 1, 2011
2.5 years
August 18, 2009
August 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
shortening length of stay (LOS)
From admision to ready to discharge.
Secondary Outcomes (2)
Hospitalization rate
From presenting to ED until admission to hospital
Improvement in clinical score (CS)
Post inhalations on presentation to the ED and daily during hospitalization
Study Arms (2)
Hypertonic saline-salbutamol combination
ACTIVE COMPARATORNaCl 5% - 4cc (with standard treatment - salbutamol 0.5cc)
normal saline-salbutamol combination
PLACEBO COMPARATORStandard treatment normal saline 4cc with salbutamol 0.5cc
Interventions
hypertonic saline 5% with 0.5cc salbutamol
normal saline - 4cc with salbutamol 0.5cc
Eligibility Criteria
You may qualify if:
- Children, age: 1-6 years old
- Presenting to the ED with acute wheezing episode
You may not qualify if:
- Any chronic (lung, cardiac, immunologic, neurologic) disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Edith Wolfson MC
Holon, Israel
Related Publications (1)
Ater D, Shai H, Bar BE, Fireman N, Tasher D, Dalal I, Ballin A, Mandelberg A. Hypertonic saline and acute wheezing in preschool children. Pediatrics. 2012 Jun;129(6):e1397-403. doi: 10.1542/peds.2011-3376. Epub 2012 May 21.
PMID: 22614767DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avigdor Mandelberg, MD
The Sackler School of Medicine, Tel Aviv University, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 18, 2009
First Posted
February 23, 2010
Study Start
January 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 9, 2011
Record last verified: 2011-08