Recruiting

Observational Study

Sponsor:

Winston Manimtim

Code:

NCT04270045

Conditions

Infant, Premature, Diseases

Bronchopulmonary Dysplasia

Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-invasive forced airway oscillometry

Study Details

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

Study ID

NCT04270045

Start date

Feb 6, 2020

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Outpatient Cohort:

  • Former preterm infants < 32 weeks at birth
  • Those with BPD based on NIH 2001 definition
  • Seen prior to 2 years 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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Single

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

Interventions

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.

Primary outcome measure

  • Forced oscillation technique measurements [ Time Frame: FOT measurement prior to bronchodilator therapy ]
  • Post-bronchodilator forced oscillation technique measurements (in subjects already receiving this therapy) [ Time Frame: FOT measurement 30 to 60minutes following bronchodilator therapy ]

Central Contacts and Locations

Central contacts

Winston M Manimtim, MD, FAAP

(816) 234-3592wmmanimtim@cmh.edu

Miah A Ruffin

(816)731-7443mruffin@cmh.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Winston M Manimtim, MD, FAAP

(816) 234-3592wmmanimtim@cmh.edu

More Information

Sponsor

Winston Manimtim

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Winston Manimtim on 2026-01-21.