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

• Sponsor: ameer asadullah gull (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04989114
• Collaborator: King Edward Medical University (Other)
• Enrollment: 96
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Acute Viral; Bronchiolitis; Bronchiolitis Acute; Bronchiolitis, Viral; Nasal Continuous Positive Airway Pressure	Device: nasal continuous positive airway pressure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 6, 2020
• Anticipated Primary Completion Date: Sep 5, 2021
• Anticipated Study Completion Date: Sep 5, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. reduction in seattle score [after 12 hours]

   seattle score will be noted and compared for both groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Hospital	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• ameer asadullah gull
• King Edward Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ameer asadullah gull, Postgraduate Resident Pediatric Medicine, King Edward Medical University
• ClinicalTrials.gov Identifier: NCT04989114
• Other Study ID Numbers: 704/RC/KEMU
• First Posted: Aug 4, 2021
• Last Update Posted: Aug 4, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis, Viral

Study Results

No Results Posted as of Aug 4, 2021