Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis

Study Overview
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Brief Summary
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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.

Official Title
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Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Hypertonic saline
* Drug: Adrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score Exclusion Criteria: Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases Known or suspected immunodeficiency Congenital malformations History of use of steroids within one week prior to presentation Severe disease requiring admission to intensive care unit/mechanical ventilation

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (HS)<br>Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes | Drug: Hypertonic saline<br>* The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.<br>|
| Active Comparator: Group 2 (Adr)<br>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<br>* The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.<br>* Other names: Epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | 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. | During hospitalization, approximately 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial change in the Wang bronchiolitis clinical severity score | 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]. | 20 minutes after the first nebulization | 
| Number of hours of intravenous fluid requirement | Intravenous fluids were given to children unable to accept orally. | During hospitalization, approximately 2 days | 
| Number of hours of oxygen requirement | Oxygen was administered when the saturation was less than 92% | Till the time the child maintained a saturation of more than 94% for at least 4 hours | 
| Number of doses of nebulization needed | 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 | During hospitalization, approximately 2 days | 
| Response after each nebulization | An improvement in the clinical severity score by at least 3 points after each nebulization. | Assessed 20 minutes after each nebulization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchiolitis, nebulization, hypertonic saline, adrenaline