Phase 4
N=64
Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Bronchiolitis · Wheezing
Bottom Line
View on ClinicalTrials.gov: NCT02233985 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Score Respiratory Distress — 8; 8; 6; 8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0.9% Sodium Chloride (Drug); 3% Sodium Chloride (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Coordinación de Investigación en Salud, Mexico
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score Respiratory Distress |
8; 8; 6; 8; 5; 8 | — |
| PRIMARY Hours of Hospital Stay |
8; 39.3 | — |
| SECONDARY Hospital Readmission |
— | — |
| SECONDARY Frequency of Complications of the Disease Itself |
— | — |
Summary
- Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to severe bronchiolitis.
Eligibility Criteria
Inclusion Criteria
- All pediatric patients aged 2 months to 24 months of age, both genders attending the pediatric emergency service.
- With first episode of wheezing associated with respiratory distress and a history of upper respiratory tract infection.
- You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu (HSJD) from 6 to 16 at entry points (moderate and severe degree).
Exclusion Criteria
- Subjects with a history of previous wheezing, asthma, or who have received bronchodilator treatment before the present illness.
- Subjects with chronic lung disease, with heart disease, with congenital or acquired anatomic abnormalities of the airway.
Data sourced from ClinicalTrials.gov (NCT02233985). 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.