Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
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|ClinicalTrials.gov Identifier: NCT04270045|
Recruitment Status : Suspended (Suspended per institutional directive due to COVID-19 Pandemic; No suspension of IRB approval)
First Posted : February 17, 2020
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment|
|Infant, Premature, Diseases Bronchopulmonary Dysplasia Respiratory Distress Syndrome||Device: Non-invasive forced airway oscillometry|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||Forced Oscillometry in Infants With Bronchopulmonary Dysplasia|
|Actual Study Start Date :||February 6, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Non-invasive forced airway oscillometry
Device: Non-invasive forced airway oscillometry
This non-invasive device will measure pulmonary mechanics in spontaneously breathing premature infants. 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.
- Forced oscillation technique measurements [ Time Frame: FOT measurement prior to bronchodilator therapy ]Baseline FOT measurements in premature infants with BPD
- Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy) [ Time Frame: FOT measurement 30 to 60minutes following bronchodilator therapy ]FOT measurements in premature infants with BPD following bronchodilator therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270045
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|