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Preterm Infant Inhaled Albuterol Dosing

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchopulmonary Dysplasia; Very Low Birth Weight

Intervention: Varied albuterol dose response (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Cynthia McEvoy, MD, MCR, Principal Investigator, Affiliation: Oregon Health and Science University
Amanda Hamilton, MD, Study Director, Affiliation: Oregon Health and Science University

Overall contact:
Amanda Hamilton, MD, Phone: 503-494-4553, Email: hamiaman@ohsu.edu

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.

Clinical Details

Official title: Albuterol Dose-Response on Pulmonary Function Testing in Preterm Infants at Risk of Bronchopulmonary Dysplasia

Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Primary outcome: Change in respiratory resistance

Secondary outcome: Comparison of responses to different albuterol doses

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.

Eligibility

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

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

Locations and Contacts

Amanda Hamilton, MD, Phone: 503-494-4553, Email: hamiaman@ohsu.edu

Doernbecher Neonatal Care Center at Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Amanda Hamilton, MD, Phone: 503-494-4553, Email: hamiaman@ohsu.edu
Cynthia McEvoy, MD, Phone: 503-494-8914, Email: mcevoyc@ohsu.edu
Additional Information

Related publications:

Blake K, Madabushi R, Derendorf H, Lima J. Population pharmacodynamic model of bronchodilator response to inhaled albuterol in children and adults with asthma. Chest. 2008 Nov;134(5):981-9. doi: 10.1378/chest.07-2991. Epub 2008 Jun 26.

Ng G, da Silva O, Ohlsson A. Bronchodilators for the prevention and treatment of chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2012 Jun 13;6:CD003214. doi: 10.1002/14651858.CD003214.pub2. Review.

Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9.

Starting date: October 2013
Last updated: May 15, 2015

Page last updated: August 23, 2015

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