A clinical trial to compare efficacy of nebulisation with hypertonic saline and epinephrine in children with Acute Bronchiolitis

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/12/006458
• Date of registration: 23-12-2015
• Prospective Registration: No
• Primary sponsor: BPKIHS
• Public title: A clinical trial to compare efficacy of nebulisation with hypertonic saline and epinephrine in children with Acute Bronchiolitis
• Scientific title: COMPARATIVE EFFICACY OF HYPERTONIC(3%) SALINE VERSUS EPINEPHRINE NEBULISATION IN CHILDREN WITH ACUTE BRONCHIOLITIS- A RANDOMISED CONTROLLED TRIAL
• Date of first enrolment: 31-08-2015
• Target sample size: 64
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12729
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Double Blind Double Dummy
• Phase: Phase 1

Countries of recruitment

Nepal

Contacts

• Name: Dr Rohan R Verma
• Affiliation: BPKIHS

• Name: Dr Rohan R Verma
• Affiliation: BPKIHS

Key inclusion & exclusion criteria

Inclusion criteria: All children between 1 month and 5 years of age with the diagnosis of acute bronchiolitis. Bronchiolitis taken as the first episode of wheezing associated with clinical evidence of viral infection (cough, coryza or fever).
Exclusion criteria: children over 5 yrs of age

• not giving consent

• Multiple episodes of wheezing

• Children already on bronchodilators or any other medication

• Children with history of allergic rhinitis, atopic dermatitis.

• Children with cardiac disease

• Children with chronic pulmonary disease

• Children with obtunded consciousness

• Children with progressive respiratory failure.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- presenting with first episode of wheeze with fever or cough. age group from 1 month to 5 years

Intervention(s)

Intervention1: Epinephrine: nebulisation with epinephrine to be given to the subjects
Control Intervention1: Hypertonic 3% sodium chloride: nebulisation to be given with 3% sodium chloride (3 ml) in the selected subjects given initially 20 min 3 doses and then 3 hourly

Primary Outcome(s)

to compare the efficacy of the nebulisation with ephrinephrine to hypertonic salineTimepoint: to compare the efficacy of the nebulisation with ephrinephrine to hypertonic saline

Secondary Outcome(s)

to compare the safety of nebulisation with epinephrine and hypertonic salineTimepoint: 1 year

Secondary ID(s)

NIL

Source(s) of Monetary Support

BPKIHS

Secondary Sponsor(s)

DEPARTMENT OF PAEDIATRICS BP Koirala Institute of Health Sciences

Ethics review

Status: Approved
Approval date: 12/08/2015
Contact:

INSTITUTIONAL REVIEW COMMITTEE