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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
Sponsor:
Information provided by (Responsible Party):
Winston Manimtim, Children's Mercy Hospital Kansas City

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)

Condition or disease Intervention/treatment
Infant, Premature, Diseases Bronchopulmonary Dysplasia Respiratory Distress Syndrome Device: Non-invasive forced airway oscillometry

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Single
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.




Primary Outcome Measures :
  1. Forced oscillation technique measurements [ Time Frame: FOT measurement prior to bronchodilator therapy ]
    Baseline FOT measurements in premature infants with BPD

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants with bronchopulmonary Dysplasia who are in room air or 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)
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.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Winston Manimtim
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Responsible Party: Winston Manimtim, Principal Investigator, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT04270045    
Other Study ID Numbers: STUDY00000912
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Infant, Premature, Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury