Phase 4
N=62
Hypertonic Saline for Acute Bronchiolitis
Bronchiolitis, Viral · Saline Solution, Hypertonic
Bottom Line
View on ClinicalTrials.gov: NCT01247064 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Respiratory Assessment Change Score (RACS) — -1.5; -4 units on a scale — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nebulized 3% saline (Drug); Nebulized 0.9% Normal Saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Assessment Change Score (RACS) |
-1.5; -4 | 0.01 sig |
| SECONDARY Rate of Hospitalization |
71; 64.5 | 0.86 |
| SECONDARY Respiratory Rate Change |
-1.8; -9.8 | 0.02 sig |
| SECONDARY Oxygen Saturation Change |
1.1; 0.1 | 0.36 |
| SECONDARY Parental Perception of Improvement of Breathing After Study Medication |
50; 54.8 | 0.62 |
Summary
The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.
Eligibility Criteria
Inclusion Criteria
- Age 8 weeks through 23 months
- First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
- Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
- Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
- Parental/guardian permission (informed consent)
Exclusion Criteria
- Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
- Chronic lung or heart disease
- Critically ill infants requiring immediate airway stabilization
- Non-English speaking parent/guardian
- Inability to take nebulized medications
Data sourced from ClinicalTrials.gov (NCT01247064). 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.