Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
Study Details
Study Description
Brief Summary
The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.
This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.
Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.
All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation >92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.
Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 (HS) Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes |
Drug: Hypertonic saline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
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| Active Comparator: Group 2 (Adr) Nebulized with 0.1 mg/kg of adrenaline (non-racemic solution, 1:1000 concentration), which was diluted in normal saline to make it a 4 ml solution, for a duration of 20 minutes |
Drug: Adrenaline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Duration of hospital stay [During hospitalization, approximately 2 days]
Duration from the time of enrolment to the point at which the discharge criteria (feeding well orally, no need for intravenous fluids, clinical severity score ≤ 3 and maintaining oxygen saturation >92% on room air for a period of more than 12 hours) are met.
Secondary Outcome Measures
- Initial change in the Wang bronchiolitis clinical severity score [20 minutes after the first nebulization]
A decrease in the Wang bronchiolitis clinical severity score by at least 3 points after 20 minutes of nebulization was considered as an improvement in the clinical condition. The Wang score ranges from 0 - 12 [0-4: mild, 5-8: moderate, 9-12: severe].
- Number of hours of intravenous fluid requirement [During hospitalization, approximately 2 days]
Intravenous fluids were given to children unable to accept orally.
- Number of hours of oxygen requirement [Till the time the child maintained a saturation of more than 94% for at least 4 hours]
Oxygen was administered when the saturation was less than 92%
- Number of doses of nebulization needed [During hospitalization, approximately 2 days]
Indications for repeat dose were if: The child had severe audible wheeze with severe respiratory distress (severity score ≥9) The child was not able to maintain saturation >92% even on an oxygen flow of 4 L/min
- Response after each nebulization [Assessed 20 minutes after each nebulization]
An improvement in the clinical severity score by at least 3 points after each nebulization.
Eligibility Criteria
Criteria
Inclusion Criteria:
• Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score
Exclusion Criteria:
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Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
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Known or suspected immunodeficiency
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Congenital malformations
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History of use of steroids within one week prior to presentation
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Severe disease requiring admission to intensive care unit/mechanical ventilation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maulana Azad Medical College | New Delhi | Delhi | India | 110002 |
Sponsors and Collaborators
- Maulana Azad Medical College
Investigators
- Principal Investigator: Jerin C Sekhar, MD, Maulana Azad Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- bronchiolitisjer90