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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Hypertonic saline
Adrenaline
Sponsored by
Maulana Azad Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring nebulization, adrenaline, hypertonic saline, bronchiolitis

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maulana Azad Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 (HS)

Group 2 (Adr)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].
Number of hours of intravenous fluid requirement
Intravenous fluids were given to children unable to accept orally.
Number of hours of oxygen requirement
Oxygen was administered when the saturation was less than 92%
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
Response after each nebulization
An improvement in the clinical severity score by at least 3 points after each nebulization.

Full Information

First Posted
July 13, 2018
Last Updated
August 2, 2018
Sponsor
Maulana Azad Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03614273
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maulana Azad Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
nebulization, adrenaline, hypertonic saline, bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (HS)
Arm Type
Active Comparator
Arm Description
Nebulized with 4 ml of 3% hypertonic saline for a duration of 20 minutes
Arm Title
Group 2 (Adr)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Other Intervention Name(s)
Epinephrine
Intervention Description
The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
Primary Outcome Measure Information:
Title
Duration of hospital stay
Description
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.
Time Frame
During hospitalization, approximately 2 days
Secondary Outcome Measure Information:
Title
Initial change in the Wang bronchiolitis clinical severity score
Description
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].
Time Frame
20 minutes after the first nebulization
Title
Number of hours of intravenous fluid requirement
Description
Intravenous fluids were given to children unable to accept orally.
Time Frame
During hospitalization, approximately 2 days
Title
Number of hours of oxygen requirement
Description
Oxygen was administered when the saturation was less than 92%
Time Frame
Till the time the child maintained a saturation of more than 94% for at least 4 hours
Title
Number of doses of nebulization needed
Description
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
Time Frame
During hospitalization, approximately 2 days
Title
Response after each nebulization
Description
An improvement in the clinical severity score by at least 3 points after each nebulization.
Time Frame
Assessed 20 minutes after each nebulization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerin C Sekhar, MD
Organizational Affiliation
Maulana Azad Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maulana Azad Medical College
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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