Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis

July 24, 2021 updated by: ameer asadullah gull

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

This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Muhammad Haroon Hamid, MBBSFCPSFRCS
  • Phone Number: 00923008880916
  • Email: haroonr5@yahoo.com

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Mayo Hospital
        • Contact:
        • Contact:
          • Muhammad Haroon Hamid, MBBSFCPSFRCS
          • Phone Number: 00923008880919
          • Email: haroonr5@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: standard care
In this arm, oxygen inhalation will be provided without positive end expiratory pressure
EXPERIMENTAL: nasal continuous positive airway pressure
In this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure
Device: nasal continuous positive airway pressure
positive end expiratory pressure will be applied by nasal continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in seattle score
Time Frame: after 12 hours
seattle score will be noted and compared for both groups
after 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ameer asadullah gull

Collaborators

King Edward Medical University

Investigators

  • Principal Investigator: Muhammad Haroon Hamid, MBBSFCPSFRCS, King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 6, 2020

Primary Completion (ANTICIPATED)

September 5, 2021

Study Completion (ANTICIPATED)

September 5, 2021

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 24, 2021

First Posted (ACTUAL)

August 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 24, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 704/RC/KEMU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on nasal continuous positive airway pressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe