Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preterm Infant Inhaled Albuterol Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02447250
Recruitment Status : Unknown
Verified October 2013 by Cynthia McEvoy, Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : May 18, 2015
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Brief Summary:
The purpose of this study is to help determine the best dose of albuterol in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication frequently used in premature infants with chronic lung disease and in people with asthma. It is believed to be safe, but the optimal dose for infants is not clear. The investigators hypothesize that albuterol may help a subset of premature infants with lung disease, but they need to determine the best dose prior to doing research about how effective it is for chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary function tests.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Very Low Birth Weight Drug: Varied albuterol dose response Phase 4

Detailed Description:
  1. Recruitment: Subjects at risk for developing bronchopulmonary dysplasia will be recruited from the Doernbecher Neonatal Care Center (DNCC).The subjects' mother will be approached by the investigators and consent obtained if she agrees to participate.
  2. Medical Record and Interview: Information about the pregnancy, delivery, and neonatal course will be obtained from the medical record. This will include maternal body mass index (BMI) at first prenatal visit, maternal age and parity, birthweight, gestational age at birth, history of maternal betamethasone for fetal lung maturation, indication for preterm delivery (e.g. pre-eclampsia, preterm labor), surfactant administration, history of intubations and duration of mechanical ventilation in the infant, current level of respiratory support, use of diuretics, bronchodilators, and corticosteroids in the neonate. A brief interview will also be obtained from the subject's mother. The questions asked will involve tobacco exposure during the pregnancy and family history of asthma. The purpose of the data collected on the infant's mother is to help identify factors that may predict which premature infants will respond to albuterol.
  3. Procedures: Pulmonary function tests (PFTs) are the procedures involved in this study. PFTs are non-invasive, require no sedation, and are commonly used to provide standard medical care to preterm infants in the DNCC. PFTs involve placing a mask over the nose and mouth during quiet sleep. We will record flow-volume loops with passive respiration and measure respiratory compliance and passive respiratory resistance (Rr) using the single breath occlusion technique. A dose of albuterol will be given after baseline measurements are obtained; the PFTs will be repeated 15 minutes after administration. The testing will be the same for each of the three sessions, except the dose of albuterol will be altered each session (see below). There will be only one session per day, and all three sessions will occur within a 7 day period. Vital signs (respiratory rate, heart rate, oxygen saturation) will be continuously monitored during the testing.
  4. Study Drug: Albuterol is a bronchodilator frequently prescribed in neonatal ICUs to help treat the symptoms of BPD. About 50% of preterm infants in the DNCC with evolving BPD have shown an improvement in their PFT after 2 puffs (180 micrograms) of albuterol (unpublished data). The typical dosing is 2-4 puffs every 4-6 hours but the optimal dose in premature infants is not known. In this study, 2 puffs will be given on the first day of PFTs, 3 puffs the second day, and 4 puffs on the third day.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Albuterol Dose-Response on Pulmonary Function Testing in Preterm Infants at Risk of Bronchopulmonary Dysplasia
Study Start Date : October 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: Single Arm: varied albuterol dose response
Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14-28 days of life. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Drug: Varied albuterol dose response
Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14-28 days of life. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Other Names:
  • Albuterol sulfate
  • Salbutamol
  • Proventil
  • ProAir
  • Ventolin




Primary Outcome Measures :
  1. Change in respiratory resistance [ Time Frame: Within one week of performing pulmonary function tests ]
    The primary outcome is the percentage of subjects who show a positive response to each dose of albuterol. A positive response is defined as a greater than or equal to 10% decrease in respiratory resistance.


Secondary Outcome Measures :
  1. Comparison of responses to different albuterol doses [ Time Frame: Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period. ]
    Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol


Other Outcome Measures:
  1. Family history of asthma and likelihood to respond to albuterol [ Time Frame: History collected at enrollment, albuterol response assessed within one week ]
  2. Maternal BMI at time of pregnancy and likelihood of positive response to albuterol [ Time Frame: Maternal information collected at enrollment; albuterol response assessed within one week ]
    Maternal BMI will be obtained from her medial record, and she will be asked about weight gain during pregnancy at time of enrollment. Results will be compared for infants born to women with a normal BMI vs. those with high BMI (>30).

  3. association of smoke exposure during pregnancy and neonatal response to albuterol [ Time Frame: Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • very low birthweight infant (<1500g)
  • gestational age <32 weeks
  • age 14-28 days
  • continuing to require respiratory support and/or supplemental oxygen

Exclusion Criteria:

  • chromosomal abnormalities
  • major congenital anomalies
  • congenital heart disease, except atrial septal defect and patent ductus arteriosus
  • clinical providers determine subject too unstable to undergo pulmonary function testing

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): NCT02447250


Contacts
Layout table for location contacts
Contact: Amanda Hamilton, MD 503-494-4553 hamiaman@ohsu.edu

Locations
Layout table for location information
United States, Oregon
Doernbecher Neonatal Care Center at Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Amanda Hamilton, MD    503-494-4553    hamiaman@ohsu.edu   
Contact: Cynthia McEvoy, MD    503-494-8914    mcevoyc@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Cynthia McEvoy, MD, MCR Oregon Health and Science University
Study Director: Amanda Hamilton, MD Oregon Health and Science University

Publications:
Layout table for additonal information
Responsible Party: Cynthia McEvoy, Associate Professor of Pediatrics, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02447250     History of Changes
Other Study ID Numbers: IRB00009883
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: October 2013

Keywords provided by Cynthia McEvoy, Oregon Health and Science University:
Bronchopulmonary dysplasia
very low birth weight
albuterol
pulmonary function test

Additional relevant MeSH terms:
Layout table for MeSH terms
Albuterol
Birth Weight
Bronchopulmonary Dysplasia
Body Weight
Signs and Symptoms
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