Preterm Infant Inhaled Albuterol Dosing

NCT02447250 | Completed Phase 4 Results

• 1 other identifier: IRB00009883
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Very Low Birth Weight

Keywords

Bronchopulmonary dysplasia; very low birth weight; albuterol; pulmonary function test

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of Participants With Positive Response at Different Albuterol Doses

  Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period.

• Birth Weight of Albuterol Responders vs Non Responders

  within one week of entering study

• Gestational Age at Birth

  within one week of entering study

• Etiology of Preterm Delivery

  within one week of entering study

Other Outcomes (3)

• Family History of Asthma and Likelihood to Respond to Albuterol

  History collected at enrollment, albuterol response assessed within one week

• Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol

  Maternal information collected at enrollment; albuterol response assessed within one week

• Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol

  Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week.

Study Arms (1)

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.

Drug: Varied albuterol dose response

Interventions

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.

Also known as: Albuterol sulfate, Salbutamol, Proventil, ProAir, Ventolin

Single Arm: varied albuterol dose response

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Doernbecher Neonatal Care Center at Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• 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.

  PMID: 18583517 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.

  PMID: 22696334 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.

  PMID: 11401896 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Albuterol; Procaterol

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Cindy McEvoy, MD
• Organization: OHSU

mcevoyc@ohsu.edu

5034940223

Study Officials

• Cynthia McEvoy, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Amanda Kim, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: October 24, 2013
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2014
• Last Updated: May 23, 2019
• Results First Posted: May 23, 2019

Record last verified: 2019-05

Locations

US (1)