Infant, Premature, DiseasesNCT04270045
Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
An observational study of Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by Winston Manimtim at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
- What is being tested?
- Non-invasive forced airway oscillometry
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- Former preterm infants < 32 weeks at birth
- Those with BPD based on NIH 2001 definition
- Seen prior to 2 years of age
Who cannot join
- Infants with BPD requiring invasive or non-invasive positive pressure ventilation
- Infants with BPD who have associated genetic diagnosis or major congenital anomalies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Winston M Manimtim, MD, FAAP, (816) 234-3592, wmmanimtim@cmh.edu
About this study
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)
Read the 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.
- Being tested
- Non-invasive forced airway oscillometry
- Medical subject headings
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive forced airway oscillometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single | Non-invasive forced airway oscillometry. Normative data will be established form term neonates without pulmonary disease Receives: Device: Non-invasive forced airway oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced oscillation technique measurements
Baseline FOT measurements in premature infants with BPD and term infants without pulmonary disease.
Measured: 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.
Measured: FOT measurement 30 to 60minutes following bronchodilator therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start6 Feb 2020
- Primary completionSep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winston Manimtim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Winston Manimtim, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270045
- Sponsor's protocol ID
- STUDY00000912
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Oscillometry in Infants With Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT04270045
- Acronym / sponsor ID
- STUDY00000912
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Winston ManimtimUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | – | Device: Non-invasive forced airway oscillometryNon-invasive forced airway oscillometry. Normative data will be established form term neonates without pulmonary disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- Former preterm infants < 32 weeks at birth
Key exclusion criteria (2 listed)
- Infants with BPD requiring invasive or non-invasive positive pressure ventilation
- Infants with BPD who have associated genetic diagnosis or major congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive forced airway oscillometryThis 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. | Device | Single |
Primary outcome
Forced oscillation technique measurements
Time frame: FOT measurement prior to bronchodilator therapy
Baseline FOT measurements in premature infants with BPD and term infants without pulmonary disease.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by Winston Manimtim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Winston M Manimtim, MD, FAAP ((816) 234-3592, wmmanimtim@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced oscillation technique measurements (time frame: FOT measurement prior to bronchodilator therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.