Phase 4
N=100
Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.
Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT01276821 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Mean Change in Clinical Severity Score — 2.26; 3.57 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- L-Epinephrine and Normal Saline (0.9%) (Drug); L-Epinephrine and Hypertonic Saline (3%) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Dr. Aayush Khanal, MD
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Clinical Severity Score |
2.26; 3.57 | <0.05 sig |
| SECONDARY Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation |
15; 35; 35; 15 | — |
| SECONDARY Relapse Rate |
15; 5; 35; 45 | — |
| SECONDARY Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week |
23; 18; 27; 32 | — |
| SECONDARY Missed Days of Work of Caregivers |
10; 3 | — |
| SECONDARY Persistence of Cough at the End of 1 Week |
37; 31; 13; 19 | — |
Summary
To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.
Eligibility Criteria
Inclusion Criteria
- Age 6 weeks to 24 Months.
- First episode of wheezing
- Fever, cough and watery nasal discharge
Exclusion Criteria
- Any underlying cardiovascular disease.
- Prior wheezing.
- Clinical Severity Score > 9.
- Atopic dermatitis, allergic rhinitis or asthma.
- Oxygen saturation (SpO2) <85% on room air.
- Obtunded consciousness.
- Previous treatment with bronchodilators within 4 hours.
- Any steroid therapy within 48 Hours.
Data sourced from ClinicalTrials.gov (NCT01276821). 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.