eCPAP Follow-up at School Age

October 5, 2026 updated by: Cynthia McEvoy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cynthia McEvoy, MD, MCR
  • Phone Number: 503-494-0085
  • Email: mcevoyc@ohsu.edu

Study Contact Backup

  • Name: Kristin Milner, CMA, BS, CCRP
  • Phone Number: 971-278-3345
  • Email: milner@ohsu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an observational follow-up study of former preterm infants who participated in the randomized clinical trial extended CPAP "parent study."

Description

Inclusion Criteria:

  • Children randomized in the parent study

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
eCPAP

Group that was assigned to Extended CPAP (eCPAP)
Other: Extended CPAP (eCPAP)

Assigned to two extra weeks of CPAP

Other Names:
  • Treatment length
dCPAP

Group that was assigned to discontinue CPAP (dCPAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between the ages of 6 and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway tree changes (structural outcomes)
Time Frame: Between the ages of 6 and 8

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.
Between the ages of 6 and 8
Molecular Endotypes
Time Frame: Between the ages of 7 and 8

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).
Between the ages of 7 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cynthia McEvoy

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Indiana University

Investigators

  • Principal Investigator: Cynthia McEvoy, MD, MCR, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 30, 2026

First Submitted That Met QC Criteria

September 30, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 8, 2026

Last Update Submitted That Met QC Criteria

October 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00030307
  • 1R01HL184382-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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