Aerosolized Albuterol Use in Severe BPD

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Bronchopulmonary dysplasia
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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