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Trial record 22 of 857 for:    ALBUTEROL

Aerosolized Albuterol Use in Severe BPD

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ClinicalTrials.gov Identifier: NCT02766673
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : July 30, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.


Condition or disease Intervention/treatment Phase
Severe Bronchopulmonary Dysplasia Drug: Albuterol Sulfate Drug: Sterile Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Aerosolized Albuterol in Mechanically Ventilated Infants With Bronchopulmonary Dysplasia (BDP)
Study Start Date : August 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


Arm Intervention/treatment
Active Comparator: Full Dose Albuterol Sulfate
2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator
Drug: Albuterol Sulfate
Subjects will receive a dose of study medication every 4 hours for 24 total hours
Other Name: Salbutamol

Active Comparator: Half Dose Albuterol Sulfate
1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator
Drug: Albuterol Sulfate
Subjects will receive a dose of study medication every 4 hours for 24 total hours
Other Name: Salbutamol

Placebo Comparator: Sterile Saline
3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator
Drug: Sterile Saline
Subjects will receive a dose of study medication every 4 hours for 24 total hours
Other Name: Placebo




Primary Outcome Measures :
  1. Change in Expiratory Flow Between Pre and Post-medication Dosing [ Time Frame: every 4 hours in each treatment group, up to 24 hours ]
    Expiratory flow at 75% of vital capacity (EF75) will be measured before beginning each treatment and again 15-30 min after each treatment phase. Therefore there will be 6 pairs (12) of EF values to determine the change in EF for each treatment. this measure is done by measuring the expiratory flow at 75% of exhalation on as measure on the flow volume loop of the ventilator. a single mechanical breath is chosen and the flow volume loop is frozen on the ventilator screen. the clinician can then scroll to measure total tidal volume for the breath, then multiple this volume by 0.25 (to ascertain the volume that the time point of 75% of exhalation), then scroll along the expiratory side of the flow volume loop until the calculated volume is reached and then the flow at that time point is recorded.


Secondary Outcome Measures :
  1. Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing [ Time Frame: every 4 hours in each treatment group, up to 24 hours ]
    Heart rate will be measured before beginning each treatment and again 15-30 min after the conclusion of each treatment phase (4 hours). Therefore there will be 6 pairs of heart rates (12 measures), to determine the change in HR for each treatment group.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766673


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Kevin Dysart, MD Children's Hospital of Philadelphia
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02766673     History of Changes
Other Study ID Numbers: 15-012264
First Posted: May 10, 2016    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Albuterol
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action