← Back to Search

Other

Hypertonic Saline + Chest Percussion for Bronchiolitis

Phase 4

Recruiting

Led By Tuan Nguyen

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Individual must have a diagnosis of acute bronchiolitis

Individual must be receiving supplemental oxygen support

Must not have

Individual admitted to the pediatric intensive care unit

Individual is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of discharge (approximately 1-5 days on average)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if using a combination of nebulized hypertonic saline and chest percussion therapy is effective in treating babies and toddlers with acute bronchiolitis. Patients aged 0 to 24

Who is the study for?

This trial is for young patients, from newborns up to 2 years old, who are hospitalized with acute bronchiolitis. The study will include those who meet the specific age requirement and have been diagnosed with this respiratory condition.

What is being tested?

The study tests if breathing in a saltwater mist (nebulized hypertonic saline) combined with tapping on the chest using special cups (chest percussion therapy) every six hours helps treat infants and toddlers hospitalized with acute bronchiolitis.

What are the potential side effects?

Possible side effects may include discomfort or coughing during nebulization or chest percussion therapy. There might also be an increased risk of temporary irritation in the airways due to inhaling the salty solution.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with acute bronchiolitis.

Select...

I am currently using supplemental oxygen.

Select...

I am under 2 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently in the pediatric intensive care unit.

Select...

I am currently using treatments like albuterol for my breathing.

Select...

I am currently taking medications like antibiotics or steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of discharge (approximately 1-5 days on average)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of discharge (approximately 1-5 days on average)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of discharge (approximately 1-5 days on average) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of Hospital Stay

Time on Supplemental Oxygen Support

Secondary study objectives

Average Heart Rate

Average Pulse Oximetry Reading

Average Respiratory Rate

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nebulized Hypertonic Saline + Chest Percussion TherapyExperimental Treatment2 Interventions

Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.

Group II: Control ArmActive Control1 Intervention

Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.

0 / 6Eligibility criteria met