Preterm Infant Inhaled Albuterol Dosing
Preterm Infant Inhaled Albuterol Dosing
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.
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 (180 micrograms) will be given
 on the first day of PFTs, 3 puffs (270 micrograms) the second day, and 4 puffs (260
 micrograms) on the third day.
Inclusion Criteria:

 -  very low birthweight infant (<1500g)

 -  gestational age at birth <32 weeks

 -  age 14 or more days and corrected to 28w0d to 33w6d gestational age

 -  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