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BiPAP for Childhood Asthma

N/A

Recruiting

Led By Patrick T Wilson, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation

Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through entire hospitalization, an average of 72 hours

Awards & highlights

Study Summary

This trial will study if BiPAP, a mask that adds pressure to the lungs, can help reduce the time of moderate to severe asthma attacks in children in the ER.

Who is the study for?

This trial is for children aged 5-17 with a prior asthma diagnosis and moderate to severe symptoms after initial treatment. They must have a PRAM score of 4+ and need continuous beta-agonist therapy. Excluded are those with non-asthma wheezing, hypercapnic respiratory failure, previous study participation, hypoxemic respiratory failure, tracheostomy or BiPAP contraindications like facial trauma.Check my eligibility

What is being tested?

The trial tests if BiPAP alongside standard nebulized albuterol can reduce the duration of beta-agonist therapy needed for kids during an asthma attack. It compares the effectiveness and side effects of actual BiPAP versus sham (fake) BiPAP in improving lung function and reducing treatment time.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the mask, issues related to pressure on lungs such as ear or sinus pain, stomach bloating, dry mouth or skin irritation where the mask touches the face.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 17 years old and have asthma.

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I have been diagnosed with asthma and prescribed medication for it.

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My asthma is severe, needing continuous treatment even after initial emergency care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four-hour study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four-hour study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and four-hour study intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of Continuous Beta-Agonist Therapy

Secondary outcome measures

Admission to Pediatric Intensive Care Unit (PICU)

Adverse Events

Change in Heart Rate

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BiPAPExperimental Treatment1 Intervention

Patients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician.

Group II: ControlPlacebo Group1 Intervention

Patients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,851,998 Total Patients Enrolled

6 Trials studying Childhood Asthma

2,086 Patients Enrolled for Childhood Asthma

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,400 Total Patients Enrolled

Patrick T Wilson, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

Media Library

Bi-level Positive Airway Pressure Clinical Trial Eligibility Overview. Trial Name: NCT05848115 — N/A

Childhood Asthma Research Study Groups: BiPAP, Control

Childhood Asthma Clinical Trial 2023: Bi-level Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT05848115 — N/A

Bi-level Positive Airway Pressure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848115 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants that are over the age of fifty-five?

"To be considered for this study, participants must be between 5 and 17 years old. The database currently lists 148 trials designed for minors and 205 studies targeting the elderly population."

Answered by AI

Are there any vacancies available to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical research project is still searching for individuals who meet the requirements and began recruiting on June 23rd 2023 with its most recent update occurring in August 17th 2023. The study requires 126 patients from 1 site."

Answered by AI

How numerous are the volunteers in this clinical research?

"Indeed, information available on clinicaltrials.gov attests that the enrollment for this research is occurring presently; it was initially made public in June 23rd 2023 and last updated August 17th of the same year. This endeavor requires 126 individuals to be enrolled from a single center."

Answered by AI

Who is eligible to be a participant in this research protocol?

"This comprehensive medical experiment is recruiting 126 minors aged 5 to 17 with a history of asthma. To be eligible, applicants must have been diagnosed by a physician and prescribed medications for their condition, achieved at least 4 points on the PRAM scale after first-line therapy (beta agonists + corticosteroids), and require continued beta-agonist treatment following initial intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

2023. "BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05848115.