Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

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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

20

Start Date

February 6, 2020

Completion Date

December 2020

Primary Completion Date

December 2020

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

July 2020