Clinical trial NCT03614273: Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis
Official title: Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: nebulization
adrenaline
hypertonic saline
bronchiolitis
Lead sponsor: Maulana Azad Medical College
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Duration of hospital stay
timeFrame: During hospitalization, approximately 2 days
Secondary outcomes:
measure: Initial change in the Wang bronchiolitis clinical severity score
timeFrame: 20 minutes after the first nebulization
measure: Number of hours of intravenous fluid requirement
timeFrame: During hospitalization, approximately 2 days
measure: Number of hours of oxygen requirement
timeFrame: Till the time the child maintained a saturation of more than 94% for at least 4 hours
measure: Number of doses of nebulization needed
timeFrame: During hospitalization, approximately 2 days
measure: Response after each nebulization
timeFrame: Assessed 20 minutes after each nebulization
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College
state: Delhi
Study officials:
affiliation: Maulana Azad Medical College
name: Jerin C Sekhar, MD
role: PRINCIPAL_INVESTIGATOR
References: