Measuring lung function in infants with bronchopulmonary dysplasia
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Children's Mercy Hospital Kansas City · NCT04270045
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 |
|---|---|
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City (other) |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT04270045 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients requiring invasive ventilation or those with significant congenital anomalies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kansas City, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome