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NCT02766673 · ClinicalTrials.gov registry record · NA
Aerosolized Albuterol Use in Severe BPD
A NA study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT02766673: Completed NA study, sponsored by Children's Hospital of Philadelphia.
NCT02766673 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02766673, a NA study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol is one of the most widely used therapies that are utilized for infants with chronic lung disease. The common practice in the N/IICU is weight base dosing of all medications. This contradicts the aerosol science recommendations, which advise not to titrate doses by weight as the patient naturally self-regulates their dose according to the change in minute ventilation with age. In addition, the wide use of aerosolized Albuterol in the infant with Bronchopulmonary Dysplasia (BPD) has little current evidence of efficacy in this disease. Understanding the appropriate dose for effective treatment as well as the indication for use in the BPD population would provide the clinician with useful guidelines. The investigators propose to analyze the safety and efficacy of aerosolized albuterol in infants with BPD comparing the recommended dose per aerosolization literature with the common dosing practices at The Children's Hospital of Philadelphia (CHOP) as well as placebo.
Primary Outcome
Expiratory flow at 75% of vital capacity (EF75) will be measured before beginning each treatment and again 15-30 min after each treatment phase. Therefore there will be 6 pairs (12) of EF values to determine the change in EF for each treatment. this measure is done by measuring the expiratory flow at 75% of exhalation on as measure on the flow volume loop of the ventilator. a single mechanical breath is chosen and the flow volume loop is frozen on the ventilator screen. the clinician can then sc
Interventions
- DRUG Sterile Saline
- DRUG Albuterol Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-08 |
| Est. Completion | 2018-06 |
| Phase | NA |
What the finished NCT02766673 record still lists
NCT02766673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sterile Saline is the first listed.
NCT02766673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02766673 about?
NCT02766673 is a clinical study titled "Aerosolized Albuterol Use in Severe BPD". Currently several dose schedules of Albuterol are administered via nebulization to infants in the neonatal and infant intensive care unit (N/IICU). As Albuterol is not FDA approved for this population (under 2 years) there is no standard recommended dose. Aerosolized Albuterol is one of the most wid...
What is the current status of trial NCT02766673?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2016-08. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02766673?
The interventions under investigation include: Sterile Saline (DRUG), Albuterol Sulfate (DRUG).
Who is sponsoring clinical trial NCT02766673?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02766673's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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