Preterm Infant Inhaled Albuterol Dosing
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Women's Studies |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2013 |
| End Date: | July 2016 |
| Contact: | Amanda Hamilton, MD |
| Email: | hamiaman@ohsu.edu |
| Phone: | 503-494-4553 |
Albuterol Dose-Response on Pulmonary Function Testing in Preterm Infants at Risk of Bronchopulmonary Dysplasia
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
