Brief Title
Aerosolized Albuterol Use in Severe BPD
Official Title
Safety and Efficacy of Aerosolized Albuterol in Mechanically Ventilated Infants With Bronchopulmonary Dysplasia (BDP)
Brief 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.
Detailed Description
This is a randomized, blinded cross-over study of infants with a diagnosis of Severe BPD that are mechanically ventilated. Participants will receive 3 sets of treatment (2.5mg Albuterol, 1.25mg Albuterol, 3ml normal saline placebo), in random order. Each treatment will be administered every 4 hours for 24 hours. After a 6 hour washout phase, the next group of interventions will be applied. Following another wash-out phase, the final group of intervention will be applied. Pulmonary mechanics from the ventilator (e.g. airway compliance, airway resistance, tidal volume, peak inspiratory pressure, Forced Expiratory Flow at 75% of forced vital capacity, etc.) and the patient short term response to therapy (heart rate, blood pressure, heart rhythm) will be assessed for the duration of the treatment period.
Study Type
Interventional
Primary Outcome
Change in Expiratory Flow Between Pre and Post-medication Dosing
Secondary Outcome
Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing
Condition
Severe Bronchopulmonary Dysplasia
Intervention
Albuterol Sulfate
Study Arms / Comparison Groups
Full Dose Albuterol Sulfate
Description: 2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
August 2016
Completion Date
June 2018
Primary Completion Date
June 2018
Eligibility Criteria
Inclusion Criteria: 1. Infants greater than or equal to 36 weeks corrected gestational age to one year of age 2. Diagnosis of BPD in accordance with The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) definition 3. May have a current order for short acting bronchodilator, not required 4. May have congenital anomalies unless one or more of the exclusion criteria are met, not required 5. Receiving conventional mechanical ventilation via an artificial airway (endotracheal tube or tracheostomy) via Draeger V500 Ventilator 6. Parental/guardian permission (informed consent) Exclusion Criteria: 1. Airway leak greater than 10% 2. Unilateral lung disease 3. Current order for inhaled anticholinergic (i.e. ipratropium bromide) 4. Active pulmonary or systemic infection 5. Scheduled order for other medication that cause bronchodilation (i.e. atrovent, magnesium sulfate, ketamine, etc.)
Gender
All
Ages
N/A - 1 Year
Accepts Healthy Volunteers
No
Contacts
Kevin Dysart, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02766673
Organization ID
15-012264
Responsible Party
Sponsor
Study Sponsor
Children's Hospital of Philadelphia
Study Sponsor
Kevin Dysart, MD, Principal Investigator, Children's Hospital of Philadelphia
Verification Date
August 2019