Preterm Infant Inhaled Albuterol Dosing

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Brief Title

Preterm Infant Inhaled Albuterol Dosing

Official Title

Albuterol Dose-Response on Pulmonary Function Testing in Preterm Infants at Risk of Bronchopulmonary Dysplasia

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in Respiratory Resistance

Secondary Outcome

 Number of Participants With Positive Response at Different Albuterol Doses

Condition

Bronchopulmonary Dysplasia

Intervention

Varied albuterol dose response

Study Arms / Comparison Groups

 Single Arm: varied albuterol dose response
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

October 24, 2013

Completion Date

December 30, 2014

Primary Completion Date

December 30, 2014

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Cynthia McEvoy, MD, MCR, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02447250

Organization ID

IRB00009883


Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University


Study Sponsor

Cynthia McEvoy, MD, MCR, Principal Investigator, Oregon Health and Science University


Verification Date

May 2019