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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: varied albuterol dose response | Experimental | Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. 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 single 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varied albuterol dose response | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Resistance | 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. | Within one week of performing pulmonary function tests |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Response at Different Albuterol Doses | Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol | Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period. |
| Measure | Description | Time Frame |
|---|---|---|
| Family History of Asthma and Likelihood to Respond to Albuterol | 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. | History collected at enrollment, albuterol response assessed within one week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia McEvoy, MD, MCR | Oregon Health and Science University | Principal Investigator |
| Amanda Kim, MD | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doernbecher Neonatal Care Center at Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18583517 | Background | 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):981-989. doi: 10.1378/chest.07-2991. Epub 2008 Jun 26. | |
| 22696334 | Background | 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. |
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1 subject was consented into the study, but then became too clinically unstable to participate in the study and remained unstable throughout the eligibility period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Varied Albuterol Dose Response | Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. 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 single 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. Varied albuterol dose response: Subjects will be evaluated in three 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 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Dose (180 mcg Albuterol) |
| |||||||||||||
| Second Dose (270 mcg Albuterol) |
| |||||||||||||
| Third Dose (360 mcg Albuterol) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Varied Albuterol Dose Response | Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. 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 single 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. Varied albuterol dose response: Subjects will be evaluated in three 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 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Respiratory Resistance | 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. | Some subjects did not receive all 3 doses (based on how they tolerated initial dose(s)) | Posted | Mean | Standard Deviation | cm h2o/mL/sec | Within one week of performing pulmonary function tests |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Varied Albuterol Dose Response | Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. 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 single 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. Resistance and compliance will be measured using the single breath occlusion technique. Varied albuterol dose response: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated heart rate above predefined criteria | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy McEvoy, MD | OHSU | 5034940223 | mcevoyc@ohsu.edu |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D017265 | Procaterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| Birth Weight of Albuterol Responders vs Non Responders |
birth weight in grams of each subject was recorded at time of enrollment |
| within one week of entering study |
| Gestational Age at Birth | Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response | within one week of entering study |
| Etiology of Preterm Delivery | Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia). | within one week of entering study |
| Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol | 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). | Maternal information collected at enrollment; albuterol response assessed within one week |
| Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol | Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants | Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week. |
| 11401896 | Background | Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available. |
|
|
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| birthweight | Mean | Full Range | grams |
|
| gestational age at birth | Mean | Full Range | weeks |
|
| respiratory support at study entry, CPAP | Count of Participants | Participants |
|
| respiratory support at study entry, mechanical ventilation | Count of Participants | Participants |
|
| history of any mechanical ventilation | Count of Participants | Participants |
|
| received surfactant | Count of Participants | Participants |
|
| received antenatal corticosteroids | Count of Participants | Participants |
|
| ever received albuterol prior to study entry | Count of Participants | Participants |
|
| received diuretics prior to study entry | Count of Participants | Participants |
|
| reason for preterm delivery: preterm labor | Count of Participants | Participants |
|
| maternal age, years (mean) | Mean | Full Range | years |
|
| maternal BMI (mean, range) | Median | Full Range | kg/ m^2 |
|
| maternal diabetes mellitus (pregestational or gestational) | Count of Participants | Participants |
|
| family history of asthma | Count of Participants | Participants |
|
| maternal smoking during pregnancy | Count of Participants | Participants |
|
| second hand smoke exposure during pregnancy | Count of Participants | Participants |
|
Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. 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 single 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.
Varied albuterol dose response: Subjects will be evaluated in three 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 2
|
|
| Secondary | Number of Participants With Positive Response at Different Albuterol Doses | Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol | Measuring Rrs can be technically challenging, particularly in premature infants, and we did not have measurable Rrs for every subject at every time point, therefore the denominator here is not the same as the total number of participants. For example, we have missing/unmeasurable Rrs for 3 subjects at the lowest albuterol dose. | Posted | Number | participants | Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period. |
|
|
|
| Secondary | Birth Weight of Albuterol Responders vs Non Responders | birth weight in grams of each subject was recorded at time of enrollment | This data included 10 subjects who responded to albuterol at at least one dose, and 3 subjects who did not show a positive response to albuterol at any dose | Posted | Mean | Standard Deviation | grams | within one week of entering study |
|
|
|
|
| Secondary | Gestational Age at Birth | Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response | We have data for 10 subjects who responded to albuterol and 3 subjects who did not respond. | Posted | Mean | Standard Deviation | weeks | within one week of entering study |
|
|
|
|
| Secondary | Etiology of Preterm Delivery | Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia). | 5 subjects were delivered due to preterm labor, and 8 delivered prematurely due to maternal indications | Posted | Count of Participants | Participants | within one week of entering study |
|
|
|
|
| Other Pre-specified | Family History of Asthma and Likelihood to Respond to Albuterol | 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. | only 2 subjects had a history of a first-degree relative (parent or sibling) with asthma | Posted | Number | participants | History collected at enrollment, albuterol response assessed within one week |
|
|
|
| Other Pre-specified | Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol | 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). | We have BMI data on 13 mothers. | Posted | Mean | Standard Deviation | kg/m^2 | Maternal information collected at enrollment; albuterol response assessed within one week |
|
|
|
|
| Other Pre-specified | Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol | Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants | We have data for 9 subjects whose mothers did not smoke and 4 subjects whose mothers smoked | Posted | Number | participants | Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week. |
|
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|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| positive Rrs response at 360 mcg albuterol |
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