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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 is a NA study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 24 participants.

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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.

Interventions

  • DRUG Sterile Saline
  • DRUG Albuterol Sulfate

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-08
Est. Completion 2018-06
Phase NA

Sponsor

Children's Hospital of Philadelphia

431 total trials

What the Registry Record Tells You About NCT02766673

The ClinicalTrials.gov registry entry for NCT02766673 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sterile Saline is the first listed.

NCT02766673 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.