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

NCT03614273 | Completed

• 1 other identifier: bronchiolitisjer90
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

nebulization; adrenaline; hypertonic saline; bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Initial change in the Wang bronchiolitis clinical severity score

  20 minutes after the first nebulization

• Number of hours of intravenous fluid requirement

  During hospitalization, approximately 2 days

• Number of hours of oxygen requirement

  Till the time the child maintained a saturation of more than 94% for at least 4 hours

• Number of doses of nebulization needed

  During hospitalization, approximately 2 days

• Response after each nebulization

  Assessed 20 minutes after each nebulization

Study Arms (2)

Group 1 (HS)

ACTIVE COMPARATOR

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

Drug: Hypertonic saline

Group 2 (Adr)

ACTIVE COMPARATOR

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

Interventions

Hypertonic saline DRUG

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

Group 1 (HS)

Adrenaline DRUG

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

Also known as: Epinephrine

Group 2 (Adr)

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score

You may not qualify if:

• 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

Sponsors & Collaborators

• Maulana Azad Medical College: lead

Study Sites (1)

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic; Epinephrine

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jerin C Sekhar, MD

  Maulana Azad Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of Pediatrics

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 3, 2018
• Study Start: March 1, 2015
• Primary Completion: February 29, 2016
• Study Completion: February 29, 2016
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

IN (1)