Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorWinston Manimtim
About this trial
The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Premature infants with BPD who are in room air based on the (per NICHD definition)
Premature infants with BPD who are receiving low flow O2 support and able to maintain normal spO2 in Room air for brief period ( up to 3 minutes) Term Cohort without pulmonary disease
Infants >36 weeks gestational age without pulmonary disease
Infants < 4 weeks of age
Disqualifiers
Infants with BPD requiring invasive or non-invasive positive pressure ventilation
Infants with BPD who have associated genetic diagnosis or major congenital anomalies.
Trial population
Premature infants with bronchopulmonary Dysplasia who are in room air or Premature infants with BPD who are receiving low flow O2 support and able to maintain normal spO2 in Room air for brief period (up to 3 minutes) Term infants without pulmonary disease. Former preterm infants (\<32 weeks) with BPD seen prior to 2 years of age in the outpatient setting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-invasive forced airway oscillometry
DeviceThis non-invasive device will measure pulmonary mechanics in spontaneously breathing premature infants and term infants without pulmonary disease. Infant will be in supine position and breathing regularly. A cushioned mask will be placed on the infant's face, covering the nose and mouth. Measurements typically take less than 20 seconds and no more than 3 repetitions will be done at each time point.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Single1 intervention
Trial outcomes
Primary outcomes
1
Forced oscillation technique measurements
Baseline FOT measurements in premature infants with BPD and term infants without pulmonary disease.
Time frame
FOT measurement prior to bronchodilator therapy2
Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy)
FOT measurements in premature infants with BPD following bronchodilator therapy.
Time frame
FOT measurement 30 to 60minutes following bronchodilator therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Winston Manimtim
Lead sponsor
Children's Mercy Hospital Kansas City
Sponsor institution
Source ClinicalTrials.gov