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 :
Completed
First Posted : May 18, 2015
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic |
Conditions |
Bronchopulmonary Dysplasia Very Low Birth Weight |
Intervention |
Drug: Varied albuterol dose response |
Enrollment | 14 |
Recruitment Details | |
Pre-assignment Details | 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. |
Arm/Group Title | 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 |
Period Title: First Dose (180 mcg Albuterol) | |
Started | 14 |
Completed | 14 |
Not Completed | 0 |
Period Title: Second Dose (270 mcg Albuterol) | |
Started | 14 |
Completed | 13 |
Not Completed | 1 |
Reason Not Completed | |
elevated HR with first dose | 1 |
Period Title: Third Dose (360 mcg Albuterol) | |
Started | 13 |
Completed | 8 |
Not Completed | 5 |
Reason Not Completed | |
Clinically unstable, unable to do PFT | 1 |
Elevated HR with 2nd dose | 4 |
Arm/Group Title | 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 |
|
Overall Number of Baseline Participants | 14 | |
![]() |
[Not Specified]
|
|
Age, Continuous
Mean (Full Range) Unit of measure: Days |
||
Number Analyzed | 14 participants | |
36
(17 to 66)
|
||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
Female |
10 71.4%
|
|
Male |
4 28.6%
|
|
birthweight
Mean (Full Range) Unit of measure: Grams |
||
Number Analyzed | 14 participants | |
895
(350 to 1293)
|
||
gestational age at birth
Mean (Full Range) Unit of measure: Weeks |
||
Number Analyzed | 14 participants | |
26.9
(24.1 to 29.9)
|
||
respiratory support at study entry, CPAP
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
12 85.7%
|
||
respiratory support at study entry, mechanical ventilation
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
2 14.3%
|
||
history of any mechanical ventilation
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
8 57.1%
|
||
received surfactant
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
7 50.0%
|
||
received antenatal corticosteroids
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
13 92.9%
|
||
ever received albuterol prior to study entry
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
0 0.0%
|
||
received diuretics prior to study entry
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
3 21.4%
|
||
reason for preterm delivery: preterm labor
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
6 42.9%
|
||
maternal age, years (mean)
Mean (Full Range) Unit of measure: Years |
||
Number Analyzed | 14 participants | |
26.4
(17 to 36)
|
||
maternal BMI (mean, range)
Median (Full Range) Unit of measure: Kg/ m^2 |
||
Number Analyzed | 14 participants | |
25.5
(18.7 to 47)
|
||
maternal diabetes mellitus (pregestational or gestational)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
4 28.6%
|
||
family history of asthma
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
2 14.3%
|
||
maternal smoking during pregnancy
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
4 28.6%
|
||
second hand smoke exposure during pregnancy
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 14 participants | |
6 42.9%
|
Name/Title: | Cindy McEvoy, MD |
Organization: | OHSU |
Phone: | 5034940223 |
EMail: | mcevoyc@ohsu.edu |
Responsible Party: | Cynthia McEvoy, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT02447250 |
Other Study ID Numbers: |
IRB00009883 |
First Submitted: | May 14, 2015 |
First Posted: | May 18, 2015 |
Results First Submitted: | October 16, 2018 |
Results First Posted: | May 23, 2019 |
Last Update Posted: | May 23, 2019 |