CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Albuterol Sulfate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02766673
NCT02766673N/ACompleted

Safety and Efficacy of Aerosolized Albuterol in Mechanically Ventilated Infants With Bronchopulmonary Dysplasia (BDP)

Children's Hospital of Philadelphia·interventional·Posted May 10, 2016·Updated Aug 28, 2019

In Brief

A clinical study evaluating Albuterol Sulfate and Sterile Saline for Severe Bronchopulmonary Dysplasia. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 10, 2016
Enrollment StartAug 1, 2016
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.1 years ago

Interventions

Albuterol Sulfatedrug

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Sterile Salinedrug

Subjects will receive a dose of study medication every 4 hours for 24 total hours