Lung FunctionNCT07860931
eCPAP Follow-up at School Age
An observational study of Lung Function, run by Cynthia McEvoy.
Trial summary
The purpose of the study is to learn more about extended continuous positive airway pressure (eCPAP) in preterm infants that may be helpful for lung health. The investigators are hoping to find out if eCPAP in stable preterm infants in the NICU results in long lasting improvements of lung function in school aged… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Function
- What is being tested?
- Extended CPAP (eCPAP)
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2033
- 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: This is an observational follow-up study of former preterm infants who participated in the randomized clinical trial extended CPAP "parent study."
Who may be able to join
- Children randomized in the parent study
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Extending Continuous Positive Airway Pressure (eCPAP) in Preterm Infants to Improve Long Term Lung Growth and Reduce Respiratory Morbidity at School Age: Follow-up of a Randomized Trial
The purpose of the study is to learn more about extended continuous positive airway pressure (eCPAP) in preterm infants that may be helpful for lung health. The investigators are hoping to find out if eCPAP in stable preterm infants in the NICU results in long lasting improvements of lung function in school aged children.
Read the detailed description
This is an observational follow-up of former preterm children from the eCPAP radnomized controlled trial (NCT#04295564), a single-center study of eCPAP vs discontinue CPAP (dCPAP) in the neonatal intensive care unit at Oregon Health \& Science University (OHSU). All former preterm infants randomized in the parent study will be approached for reconsent into this follow-up study. Investigartors will determine if eCPAP for stable preterm infants in the NICU results in sustained improvement of lung function (primary outcome spirometry) and less respiratory morbidity (wheeze), at school age. Investigators will determine if eCPAP in the NICU results in an airway tree with a larger cross- sectional area and greater lung volume at school age, which is associated with less respiratory morbidity. Additionally, investigators will obtain detailed biological data (DNA methylation and transcriptomics using nasal epithelium as a proxy for airway epithelium), to identify participants that share common molecular signatures (biological endotypes).
- Conditions
- Lung Function
- Being tested
- Extended CPAP (eCPAP)
- Keywords
- extended CPAP, eCPAP, Lung Function, NICU, Prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended CPAP (eCPAP)Other
Also called Treatment length
Assigned to two extra weeks of CPAP
| Study group | Role | What they receive |
|---|---|---|
| eCPAP | Group that was assigned to Extended CPAP (eCPAP) Receives: Other: Extended CPAP (eCPAP) | |
| dCPAP | Group that was assigned to discontinue CPAP (dCPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained improvement of lung function (functional outcomes)
Determine if eCPAP for preterm infants in the NICU results in sustained improvement of lung function (primary outcome spirometry) and less respiratory morbidity (wheeze) at school age.
Measured: Between the ages of 6 and 8
Secondary outcomes (2)
Airway tree changes (structural outcomes)
Determine via a single low dose high resolution computed tomography (HRCT) of the chest if eCPAP in the NICU results in an airway tree with a larger cross-sectional area and greater lung volume at school age, which is associated with less respiratory morbidity.
Measured: Between the ages of 6 and 8
Molecular Endotypes
Detailed biological data (DNA methylation and transcriptomics using nasal epithelium as a proxy for airway epithelium), will be used to identify patients that share common molecular signatures (biological endotypes).
Measured: Between the ages of 7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung FunctionStudies 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cynthia McEvoy
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Indiana University
- Responsible party
- Sponsor-investigator, Cynthia McEvoy, Oregon Health and Science University
- Investigators
- Cynthia McEvoy, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860931
- Sponsor's protocol ID
- STUDY00030307
- Other IDs
- 1R01HL184382-01
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McEvoy CT, MacDonald KD, Go MA, Milner K, Harris J, Schilling D, Olson M, Tiller C, Slaven JE, Bjerregaard J, Vu A, Martin A, Mamidi R, Schelonka RL, Morris CD, Tepper RS. Extended Continuous Positive Airway Pressure in Preterm Infants Increases Lung Growth at 6 Months: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Apr;211(4):610-618. doi: 10.1164/rccm.202411-2169OC.
PubMed 39977011
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Continuous Positive Airway Pressure (eCPAP) in Preterm Infants to Improve Long Term Lung Growth and Reduce Respiratory Morbidity at School Age: Follow-up of a Randomized Trial
- ClinicalTrials.gov ID
- NCT07860931
- Acronym / sponsor ID
- STUDY00030307
- Conditions
- Lung Function
- Keywords
- extended CPAP, eCPAP, Lung Function, NICU, Prematurity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Cynthia McEvoyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Indiana University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 6 Oct 2026 (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 the study is to learn more about extended continuous positive airway pressure (eCPAP) in preterm infants that may be helpful for lung health. The investigators are hoping to find out if eCPAP in stable preterm infants in the NICU results in long lasting improvements of lung function in school aged children.
Detailed description
This is an observational follow-up of former preterm children from the eCPAP radnomized controlled trial (NCT#04295564), a single-center study of eCPAP vs discontinue CPAP (dCPAP) in the neonatal intensive care unit at Oregon Health \& Science University (OHSU). All former preterm infants randomized in the parent study will be approached for reconsent into this follow-up study. Investigartors will determine if eCPAP for stable preterm infants in the NICU results in sustained improvement of lung function (primary outcome spirometry) and less respiratory morbidity (wheeze), at school age. Investigators will determine if eCPAP in the NICU results in an airway tree with a larger cross- sectional area and greater lung volume at school age, which is associated with less respiratory morbidity. Additionally, investigators will obtain detailed biological data (DNA methylation and transcriptomics using nasal epithelium as a proxy for airway epithelium), to identify participants that share common molecular signatures (biological endotypes).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCPAP | – | Other: Extended CPAP (eCPAP)Group that was assigned to Extended CPAP (eCPAP) |
| dCPAP | – | –Group that was assigned to discontinue CPAP (dCPAP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is an observational follow-up study of former preterm infants who participated in the randomized clinical trial extended CPAP "parent study."
Key inclusion criteria (1 listed)
- Children randomized in the parent study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Extended CPAP (eCPAP)Also: Treatment lengthAssigned to two extra weeks of CPAP | Other | eCPAP |
Primary outcome
Sustained improvement of lung function (functional outcomes)
Time frame: Between the ages of 6 and 8
Determine if eCPAP for preterm infants in the NICU results in sustained improvement of lung function (primary outcome spirometry) and less respiratory morbidity (wheeze) at school age.
2 secondary outcomes
Airway tree changes (structural outcomes)
Time frame: Between the ages of 6 and 8
Molecular Endotypes
Time frame: Between the ages of 7 and 8
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 8 Oct 2026.
- Background: PubMed 39977011McEvoy CT, MacDonald KD, Go MA, Milner K, Harris J, Schilling D, Olson M, Tiller C, Slaven JE, Bjerregaard J, Vu A, Martin A, Mamidi R, Schelonka RL, Morris CD, Tepper RS. Extended Continuous Positive Airway Pressure in Preterm Infants Increases Lung Growth at 6 Months: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Apr;211(4):610-618. doi: 10.1164/rccm.202411-2169OC.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Function
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Enrolling by invitationObservational study
Service and Health Among Deployed Veterans
Pulmonary Function
RecruitingObservational study
Respiratory Progression in Adults With Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy (DMD), Respiratory Function Decline
RecruitingPhase 2
Ongoing Lung Decline With Age Intensified Response
Age-Related Lung Function Decline
RecruitingObservational study
Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema
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.
Cynthia McEvoy, MD, MCR principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function, run by Cynthia McEvoy.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Cynthia McEvoy, MD, MCR (503-494-0085, mcevoyc@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained improvement of lung function (functional outcomes) (time frame: Between the ages of 6 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860931, which also lists 1 linked publication.
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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.