Measuring lung function in infants with bronchopulmonary dysplasia
Official title: Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Run by Children's Mercy Hospital Kansas City · NCT04270045 · Data updated 2026-11-12
This study is testing a new device to measure lung function in sleeping infants with bronchopulmonary dysplasia to help better understand their breathing problems.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Status | Recruiting |
| Started | February 6, 2020 |
| Main results expected | September 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT04270045 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include premature infants with BPD who are stable on room air or low flow oxygen, as well as term infants without pulmonary disease.
✕Probably not a fit
Patients requiring invasive ventilation or those with significant congenital anomalies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to utilize the forced oscillometry technique (FOT) to assess pulmonary mechanics and function in both term and premature infants diagnosed with bronchopulmonary dysplasia (BPD). The FOT is a non-invasive method that measures respiratory mechanics without requiring infants to perform specific breathing maneuvers, making it suitable for this vulnerable population. The study will employ a new device called tremoflo N-100, designed specifically for infants, to measure lung function quickly while they are sleeping. This approach seeks to provide clinically meaningful data that can enhance the understanding and management of respiratory conditions in infants.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for assessing lung function in infants with BPD, potentially enhancing treatment strategies.
How similar studies have gone: While the forced oscillometry technique has been successful in adults and older children, its application in infants is largely experimental, making this a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Preterm Cohort: * 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 Outpatient Cohort: * Former preterm infants \< 32 weeks at birth * Those with BPD based on NIH 2001 definition * Seen prior to 2 years of age Exclusion Criteria: * Infants with BPD requiring invasive or non-invasive positive pressure ventilation * Infants with BPD who have associated genetic diagnosis or major congenital anomalies.
Where it's running
-
Children's Mercy Hospital
Kansas City, Missouri, United States Recruiting
Study contacts
- Study coordinator: Winston M Manimtim, MD, FAAP
- Email: wmmanimtim@cmh.edu
- Phone: (816) 234-3592
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.