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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614273
• Other study ID #: bronchiolitisjer90
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: February 29, 2016

Study information

• Verified date: August 2018
• Source: Maulana Azad Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Hypertonic saline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
• Adrenaline
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Locations

Country	Name	City	State
India	Maulana Azad Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Maulana Azad Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of hours of intravenous fluid requirement	Intravenous fluids were given to children unable to accept orally.	During hospitalization, approximately 2 days
Secondary	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
Secondary	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
Secondary	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