Back to resultsNasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
Primary Purpose
Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
nasal continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis Acute Viral
Eligibility Criteria
Inclusion Criteria:
- Children presenting with history of cough, and tachypnea and wheezing on clinical examination
Exclusion Criteria:
- Patients needing mechanical ventilation at the time of admission
- Patients whose caretakers refuse written informed consent
- Patients having consolidation on chest X-Ray
Sites / Locations
- Mayo HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard care
nasal continuous positive airway pressure
Arm Description
In this arm, oxygen inhalation will be provided without positive end expiratory pressure
In this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure
Outcomes
Primary Outcome Measures
reduction in seattle score
seattle score will be noted and compared for both groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04989114
First Posted
July 14, 2021
Last Updated
July 24, 2021
Sponsor
ameer asadullah gull
Collaborators
King Edward Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04989114
Brief Title
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
Official Title
Effectiveness of Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Comparison to Standard Care in Children With Bronchiolitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2020 (Actual)
Primary Completion Date
September 5, 2021 (Anticipated)
Study Completion Date
September 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ameer asadullah gull
Collaborators
King Edward Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis
Detailed Description
In this study, after taking consent from caretakers, patients of brochiolitis will be randomly assigned to either a standard care group or a nasal continuous positive airway pressure group. Both groups will be followed for respiratory distress. Respiratory distress will be compared by using Seattle sore of respiratory distress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute, Bronchiolitis, Viral, Nasal Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
No Intervention
Arm Description
In this arm, oxygen inhalation will be provided without positive end expiratory pressure
Arm Title
nasal continuous positive airway pressure
Arm Type
Experimental
Arm Description
In this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure
Intervention Type
Device
Intervention Name(s)
nasal continuous positive airway pressure
Intervention Description
positive end expiratory pressure will be applied by nasal continuous positive airway pressure
Primary Outcome Measure Information:
Title
reduction in seattle score
Description
seattle score will be noted and compared for both groups
Time Frame
after 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children presenting with history of cough, and tachypnea and wheezing on clinical examination
Exclusion Criteria:
Patients needing mechanical ventilation at the time of admission
Patients whose caretakers refuse written informed consent
Patients having consolidation on chest X-Ray
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ameer Asadullah Gull, MBBS
Phone
00923084860184
Email
hellowgull@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Haroon Hamid, MBBSFCPSFRCS
Phone
00923008880916
Email
haroonr5@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Haroon Hamid, MBBSFCPSFRCS
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameer Asadullah Gull, MBBS
Phone
00923084860184
Email
hellowgull@yahoo.com
First Name & Middle Initial & Last Name & Degree
Muhammad Haroon Hamid, MBBSFCPSFRCS
Phone
00923008880919
Email
haroonr5@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
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