Actively Recruiting
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Led by Winston Manimtim · Updated on 2026-01-21
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a non-invasive method called forced oscillometry technique (FOT) to measure lung function and airway mechanics in premature and term infants with bronchopulmonary dysplasia (BPD). This study aims to establish normal lung function values in healthy term infants and to understand how infants with BPD respond to bronchodilator therapy, considering genetic factors that may influence treatment response. The study uses a device called tremoflo N-100 designed specifically for newborns and infants up to 2 years old. It measures lung function in a few minutes while the infant is sleeping by applying small pressure waves during normal breathing through a cushioned mask. Measurements are taken before and after bronchodilator therapy in infants with BPD. The study includes both preterm infants with BPD and healthy term infants without lung disease to collect comparative data. Participants will have lung function assessed using the FOT device while lying down and breathing normally. Measurements typically take less than 20 seconds and are repeated up to three times at each visit. Researchers will analyze lung mechanics before and after bronchodilator treatment to study airway obstruction and drug responsiveness. The study will also gather genetic information to explore variability in treatment effects. Participation involves outpatient visits and will continue until the infant is under 2 years of age.
CONDITIONS
Brief Title
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature infants with bronchopulmonary dysplasia (BPD) who are in room air or receiving low flow oxygen but able to maintain normal oxygen levels briefly
- Infants more than 36 weeks gestational age without pulmonary disease
- Infants younger than 4 weeks of age
- Former preterm infants born before 32 weeks gestation with BPD seen before 2 years of age
You will not qualify if you...
- Infants with BPD requiring invasive or non-invasive positive pressure ventilation
- Infants with BPD who have a genetic diagnosis or major congenital anomalies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years for former preterm infants with bronchopulmonary dysplasia
Participants undergo non-invasive forced airway oscillometry to measure pulmonary mechanics while breathing normally. Measurements take less than 20 seconds and are repeated up to 3 times at each time point.
1 to 2 visits depending on participant age and therapy status
Trial Site Locations
Total: 1 location
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
W
Winston M Manimtim, MD, FAAP
M
Miah A Ruffin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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