Brief Title
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Official Title
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
Brief Summary
The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary
mechanics and function in premature infants with bronchopulmonary dysplasia (BPD)
Detailed Description
Pulmonary function testing has been the standard of care to diagnose and evaluate response to
therapy in various respiratory diseases in adults and children. There are several equipment
and techniques that are FDA approved for these purposes. However, there are currently no lung
function tests that are practically feasible, clinically meaningful and widely used in
infants.
The forced oscillation technique (FOT) is a non-invasive method that had been used to measure
respiratory mechanics. FOT employs small amplitude pressure oscillations superimposed on the
normal breathing and therefore has the advantage over conventional lung function techniques
that it does not require the performance of respiratory maneuvers. To date, the use of this
technique is FDA approved in adults and children but remains largely experimental in infants
and newborns. THORASYS has recently developed a new respiratory function test device aimed
specifically at newborn and infants (0 - 2 years age group) called tremoflo N-100 ("Neo").
This new device measures lung function in only a few minutes while the newborn or infant is
sleeping normally. It uses an adapted version of the Airwave Oscillometry (AOS) to calculate
the impedance of the lungs and quantify airway obstruction.
Diuretics and bronchodilators are two on the most commonly used medications to ameliorate the
symptoms of BPD. The benefits of these therapies have not been shown to prevent the
development of BPD in a randomized control trial (RCT). More recently, there have been some
evidence from pharmacogenetic studies that the variability in bronchodilator responsiveness
in patients with asthma, (and possibly BPD) may lie on the gene encoding the B2-adrenergic
receptor (ADRB2) as well as within the associated G-protein receptor pathway, the nitric
oxide biosynthetic pathway and other novel loci identified in recent genome-wide studies.
This part of the study will be hypothesis generating to try to understand the variability in
bronchodilator response in infants with BPD.
Study Type
Observational
Primary Outcome
Forced oscillation technique measurements
Condition
Infant, Premature, Diseases
Intervention
Non-invasive forced airway oscillometry
Study Arms / Comparison Groups
Single
Description: Non-invasive forced airway oscillometry
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
February 6, 2020
Completion Date
December 2024
Primary Completion Date
December 2024
Eligibility Criteria
Inclusion Criteria:
- 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)
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, (816) 234-3592, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04270045
Organization ID
STUDY00000912
Responsible Party
Sponsor-Investigator
Study Sponsor
Winston Manimtim
Study Sponsor
, ,
Verification Date
June 2022