Doernbecher Neonatal Care Center at Oregon Health & Science University
Portland, Oregon, 97239, United States
NCT Number: NCT02447250
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate 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.
Looking for future studies?
Notify Me14 day and older
All sexes
Interventional
Phase 4
Portland, Oregon, 97239, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to 33w6d. 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
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 (Rrs). The change in RRs was measured at baseline and again after each dose of albuterol. All measurements were taken within a 7 day time frame for each subject such that each subject would have up to 3 results measured during a 7 day period, if he/she were able to complete three sets of PFTs according to study protocol. The change in Rrs was calculated by subtracting the baseline Rrs from the post-albuterol Rrs.
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
Time frame: within one week of entering study
birth weight in grams of each subject was recorded at time of enrollment
Time frame: within one week of entering study
Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response
Time frame: within one week of entering study
Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia).
Time frame: History collected at enrollment, albuterol response assessed within one week
Family history was obtained from verbal history by subject's mother at time of enrollment in study. A positive family history was noted if a first degree relative of the subject (infant) had a diagnosis of asthma.
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 obese BMI (>30).
Time frame: Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week.
Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants
Oregon Health and Science University
Other
Albuterol Dose-Response on Pulmonary Function Testing in Preterm Infants at Risk of Bronchopulmonary Dysplasia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05898022
Bronchopulmonary Dysplasia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Atlanta, Georgia, United States
View Trial DetailsNCT06110481
Bronchial Diseases, Bronchial Hyperreactivity
Prague, Czechia
View Trial DetailsNCT03540680
Bronchopulmonary Dysplasia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Créteil, France
View Trial DetailsNCT04107701
Bronchopulmonary Dysplasia, Chronic Lung Disease of Newborn
Boston, Massachusetts, United States
View Trial Details