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

NCT ID: NCT03614273

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2016-02-29

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 (HS)

Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes

Group Type: ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type: DRUG

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

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

Group Type: ACTIVE_COMPARATOR

Adrenaline

Intervention Type: DRUG

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Interventions

Hypertonic saline

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Intervention Type: DRUG

Adrenaline

The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.

Intervention Type: DRUG

Other Intervention Names

Epinephrine

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maulana Azad Medical College

OTHER

Sponsor Role: lead

Responsible Party

Jerin C Sekhar

Senior Resident, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerin C Sekhar, MD

Role: PRINCIPAL_INVESTIGATOR

Maulana Azad Medical College

Locations

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

bronchiolitisjer90

Identifier Type: -

Identifier Source: org_study_id