Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

The purpose of this study is to use forced oscillometry technique (FOT) to measure pulmonary mechanics and function in in term infants and premature infants with bronchopulmonary dysplasia (BPD)

Study Overview

• Status: Recruiting
• Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
• Intervention / Treatment: 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. Normative data will be established in term neonates.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Winston M Manimtim, MD, FAAP; Phone Number: (816) 234-3592; Email: wmmanimtim@cmh.edu
• Study Contact Backup: Name: Cheri A Gauldin, RN; Phone Number: (816) 234-3596; Email: cagauldin@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital
      • Contact: Winston M Manimtim, MD, FAAP; Phone Number: 816-234-3592; Email: wmmanimtim@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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) Term infants without pulmonary disease.

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single; Non-invasive forced airway oscillometry. Normative data will be established form term neonates without pulmonary disease

Device: Non-invasive forced airway oscillometry; This non-invasive device will measure pulmonary mechanics in spontaneously breathing premature infants and term infants without pulmonary disease. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced oscillation technique measurements	Baseline FOT measurements in premature infants with BPD and term infants without pulmonary disease.	FOT measurement prior to bronchodilator therapy
Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy)	FOT measurements in premature infants with BPD following bronchodilator therapy.	FOT measurement 30 to 60minutes following bronchodilator therapy

Collaborators and Investigators

• Sponsor: Winston Manimtim

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
• Other Study ID Numbers: STUDY00000912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No