Aerosolized Albuterol Use in Severe BPD

Completed · Not applicable · Has a placebo group

Conditions studied: Severe Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT02766673

Run by

Children's Hospital of Philadelphia

People needed

24

Starts

2016-08-01

Expected to finish

2018-06-01

Last updated by the study team

2019-08-28

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants greater than or equal to 36 weeks corrected gestational age to one year of age
• Diagnosis of BPD in accordance with The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) definition
• May have a current order for short acting bronchodilator, not required
• May have congenital anomalies unless one or more of the exclusion criteria are met, not required
• Receiving conventional mechanical ventilation via an artificial airway (endotracheal tube or tracheostomy) via Draeger V500 Ventilator
• Parental/guardian permission (informed consent)

You may not qualify if…

• Airway leak greater than 10%
• Unilateral lung disease
• Current order for inhaled anticholinergic (i.e. ipratropium bromide)
• Active pulmonary or systemic infection
• Scheduled order for other medication that cause bronchodilation (i.e. atrovent, magnesium sulfate, ketamine, etc.)

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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