Aerosolized Albuterol Use in Severe BPD

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Severe Bronchopulmonary Dysplasia

Treatments: Drug: Sterile Saline; Drug: Albuterol Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT02766673

15-012264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Full Dose Albuterol Sulfate

Active Comparator group

Description:

2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator

Treatment:

Drug: Albuterol Sulfate

Half Dose Albuterol Sulfate

Active Comparator group

Description:

1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator

Treatment:

Drug: Albuterol Sulfate

Sterile Saline

Placebo Comparator group

Description:

3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator

Treatment:

Drug: Sterile Saline