Aerosolized Albuterol Use in Severe BPD

NCT ID: NCT02766673

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-06-30

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.

Conditions

Severe Bronchopulmonary Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Full Dose Albuterol Sulfate

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

Group Type: ACTIVE_COMPARATOR

Albuterol Sulfate

Intervention Type: DRUG

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Half Dose Albuterol Sulfate

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

Group Type: ACTIVE_COMPARATOR

Albuterol Sulfate

Intervention Type: DRUG

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Sterile Saline

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

Group Type: PLACEBO_COMPARATOR

Sterile Saline

Intervention Type: DRUG

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Interventions

Albuterol Sulfate

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Intervention Type: DRUG

Sterile Saline

Subjects will receive a dose of study medication every 4 hours for 24 total hours

Intervention Type: DRUG

Other Intervention Names

Salbutamol; Placebo

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

Exclusion Criteria

5. Receiving conventional mechanical ventilation via an artificial airway (endotracheal tube or tracheostomy) via Draeger V500 Ventilator

6. Parental/guardian permission (informed consent)

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.)

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Dysart, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-012264

Identifier Type: -

Identifier Source: org_study_id