N/A N=24 Randomized Triple-blind Treatment

Aerosolized Albuterol Use in Severe BPD

Severe Bronchopulmonary Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT02766673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Change in Expiratory Flow Between Pre and Post-medication Dosing — 0.38; 0.70; 0.45 L/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Albuterol Sulfate (Drug); Sterile Saline (Drug)
Age: Pediatric
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Expiratory Flow Between Pre and Post-medication Dosing	0.38; 0.70; 0.45	—
SECONDARY Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing	0.074; 0.031; 0.009	—

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.

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02766673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.