At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Aerosolized Albuterol in Mechanically Ventilated Infants With Bronchopulmonary Dysplasia (BDP)
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
Timeline
Interventions
Subjects will receive a dose of study medication every 4 hours for 24 total hours
Subjects will receive a dose of study medication every 4 hours for 24 total hours