N/A
N=52
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis
Acute Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT02029040 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Respiratory Assessment Change Score (RACS) — 1.68; 1.70 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3% Hypertonic Saline (Drug); 0.9 % normal saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Assessment Change Score (RACS) |
1.68; 1.70 | — |
| SECONDARY Rate of Hospitalizations |
9; 11 | — |
Summary
This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.
Eligibility Criteria
Inclusion Criteria
- Children 2-12 months of age presenting to Emergency Department
- Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles
- Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist
Exclusion Criteria
- Previous history of wheezing
- Known heart or lung disease
- Premature birth defined as birth before 37 weeks gestation
- Immunosuppression or immunodeficiency
- Treatment with corticosteroids in the previous 48 hours
- Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration
- Oxygen saturation <85% on room air at the time of recruitment
Data sourced from ClinicalTrials.gov (NCT02029040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.