Aerosolized Albuterol Use in Severe BPD

NCT02766673 | Completed Results

• 1 other identifier: 15-012264
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• Change in Expiratory Flow Between Pre and Post-medication Dosing

  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.

  every 4 hours in each treatment group, up to 24 hours

Secondary Outcomes (1)

• Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing

  every 4 hours in each treatment group, up to 24 hours

Study Arms (3)

Full Dose Albuterol Sulfate

ACTIVE COMPARATOR

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

Drug: Albuterol Sulfate

Half Dose Albuterol Sulfate

ACTIVE COMPARATOR

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

Drug: Albuterol Sulfate

Sterile Saline

PLACEBO COMPARATOR

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

Drug: Sterile Saline

Interventions

Albuterol Sulfate DRUG

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

Also known as: Salbutamol

Full Dose Albuterol Sulfate; Half Dose Albuterol Sulfate

Sterile Saline DRUG

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

Also known as: Placebo

Sterile Saline

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Receiving conventional mechanical ventilation via an artificial airway (endotracheal tube or tracheostomy) via Draeger V500 Ventilator
• Parental/guardian permission (informed consent)
• 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.)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Natalie Napolitano, MPH, RRT-NPS, FAARC
• Organization: Children's Hospital of Philadelphia

napolitanon@email.chop.edu

215-590-1708

Study Officials

• Kevin Dysart, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 10, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)