NCT04989114

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

July 14, 2021

Last Update Submit

July 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • reduction in seattle score

    seattle score will be noted and compared for both groups

    after 12 hours

Study Arms (2)

standard care

NO INTERVENTION

In this arm, oxygen inhalation will be provided without positive end expiratory pressure

nasal continuous positive airway pressure

EXPERIMENTAL

In this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure

Device: nasal continuous positive airway pressure

Interventions

positive end expiratory pressure will be applied by nasal continuous positive airway pressure

nasal continuous positive airway pressure

Eligibility Criteria

Age2 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children presenting with history of cough, and tachypnea and wheezing on clinical examination

You may not qualify if:

  • Patients needing mechanical ventilation at the time of admission
  • Patients whose caretakers refuse written informed consent
  • Patients having consolidation on chest X-Ray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

BronchiolitisBronchiolitis, Viral

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesVirus Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Muhammad Haroon Hamid, MBBSFCPSFRCS

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameer Asadullah Gull, MBBS

CONTACT

Muhammad Haroon Hamid, MBBSFCPSFRCS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postgraduate Resident Pediatric Medicine

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 4, 2021

Study Start

September 6, 2020

Primary Completion

September 5, 2021

Study Completion

September 5, 2021

Last Updated

August 4, 2021

Record last verified: 2021-07

Locations