Forced Oscillometry in Infants With Bronchopulmonary Dysplasia

NCT04270045 | Recruiting

• 1 other identifier: STUDY00000912
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single

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

Device: Non-invasive forced airway oscillometry

Interventions

Non-invasive forced airway oscillometry DEVICE

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.

Single

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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. Former preterm infants (\<32 weeks) with BPD seen prior to 2 years of age in the outpatient setting.

You may qualify if:

• 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
• Outpatient Cohort:
• Former preterm infants \< 32 weeks at birth
• Those with BPD based on NIH 2001 definition
• Seen prior to 2 years of age

You may not qualify if:

• Infants with BPD requiring invasive or non-invasive positive pressure ventilation
• Infants with BPD who have associated genetic diagnosis or major congenital anomalies.

Sponsors & Collaborators

• Winston Manimtim: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Winston M Manimtim, MD, FAAP

CONTACT

(816) 234-3592; wmmanimtim@cmh.edu

Miah A Ruffin

CONTACT

(816)731-7443; mruffin@cmh.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: February 6, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)