Bronchiolitis Acute ViralNCT04989114
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis
A study testing nasal continuous positive airway pressure in people with Bronchiolitis Acute Viral and Bronchiolitis, run by ameer asadullah gull at 1 site in Pakistan.
Trial summary
This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute
- What is being tested?
- nasal continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Sep 2020to 5 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children presenting with history of cough, and tachypnea and wheezing on clinical examination
Who cannot join
- Patients needing mechanical ventilation at the time of admission
- Patients whose caretakers refuse written informed consent
- Patients having consolidation on chest X-Ray
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Mayo Hospital
Lahore, Punjab Province, 54000
Ameer Asadullah Gull, MBBS, 00923084860184, hellowgull@yahoo.com
Muhammad Haroon Hamid, MBBSFCPSFRCS, 00923008880919, haroonr5@yahoo.com
About this study
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
This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis
Read the 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.
- Conditions
- Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute, Bronchiolitis, Viral, Nasal Continuous Positive Airway Pressure
- Being tested
- nasal continuous positive airway pressure
- Medical subject headings
- Bronchiolitis, Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal continuous positive airway pressureDevice
positive end expiratory pressure will be applied by nasal continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: nasal continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in seattle score
seattle score will be noted and compared for both groups
Measured: after 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start6 Sep 2020
- Primary completion5 Sep 2021 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Acute ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ameer asadullah gull
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Sponsor-investigator, ameer asadullah gull, King Edward Medical University
- Investigators
- Muhammad Haroon Hamid, MBBSFCPSFRCS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989114
- Sponsor's protocol ID
- 704/RC/KEMU
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04989114
- Acronym / sponsor ID
- 704/RC/KEMU
- Conditions
- Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute, Bronchiolitis, Viral, Nasal Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- ameer asadullah gullUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- 5 Sep 2021 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –In this arm, oxygen inhalation will be provided without positive end expiratory pressure |
| nasal continuous positive airway pressure | Experimental | Device: nasal continuous positive airway pressureIn this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children presenting with history of cough, and tachypnea and wheezing on clinical examination
Key exclusion criteria (3 listed)
- Patients needing mechanical ventilation at the time of admission
- Patients whose caretakers refuse written informed consent
- Patients having consolidation on chest X-Ray
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal continuous positive airway pressurepositive end expiratory pressure will be applied by nasal continuous positive airway pressure | Device | nasal continuous positive airway pressure |
Primary outcome
reduction in seattle score
Time frame: after 12 hours
seattle score will be noted and compared for both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Haroon Hamid, MBBSFCPSFRCS principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal continuous positive airway pressure in people with Bronchiolitis Acute Viral and Bronchiolitis, run by ameer asadullah gull at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ameer Asadullah Gull, MBBS (00923084860184, hellowgull@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in seattle score (time frame: after 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.