NeonatalNCT04295564

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

A study testing Additional 2 weeks of CPAP in people with Neonatal and Premature Birth, run by Cynthia McEvoy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 12 weeks
Conditions the study is for: Neonatal, Premature Birth, Respiratory Distress Syndrome
What is being tested?: Additional 2 weeks of CPAP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2020to 15 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 day to 12 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Infants born at >24 to ≤ 32 weeks gestation
Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)

Who cannot join

Significant congenital heart disease
Major malformations
Chromosomal anomalies
Culture proven sepsis at consent
Complex maternal medical conditions
Clinical instability

Show all 10Show fewer

Multiple gestations > twins
<3rd or >97th percentile for weight85
Participating in another neonatal randomized clinical trial with a competing outcome
Mother/legal guardian without stable method of communication

Trial locations and contacts

1 site in 1 country.

United States1 site

Doernbecher Neonatal Care Center at Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial

Read the detailed description

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.

Conditions: Neonatal, Premature Birth, Respiratory Distress Syndrome
Being tested: Additional 2 weeks of CPAP
Medical subject headings: Premature Birth, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Additional 2 weeks of CPAPOther
Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

Study groups in NCT04295564
Study group	Role	What they receive
eCPAP	Experimental	Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met. Receives: Other: Additional 2 weeks of CPAP
dCPAP	No intervention	Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

What is being measured

The primary outcome is the main question the study is designed to answer.

Alveolar Volume
Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.
Measured: 4 - 8 months of age

Secondary outcomes (2)

Lung Diffusion
Establish that 2 extra weeks of CPAP in stable preterm infants increases lung diffusion at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Measurements of lung diffusion were obtained at the same time as measurements of alveolar volume using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.
Measured: 4 - 8 months of age
Forced Expiratory Flows at 50% of the Expired Volume (FEF50)
Establish that 2 extra weeks of CPAP in stable preterm infants increases forced expiratory flows at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Forced expiratory flows were measured using the raised volume rapid thoracic compression technique following specific American Thoracic Society and European Respiratory Society criteria for acceptance.
Measured: 4 - 8 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202015 Mar 2024

First posted4 Mar 2020
Study start10 Jan 2020
Primary completion18 Sep 2023
Study completion15 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for NeonatalStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04295564
Sponsor's protocol ID: eCPAP
Other IDs: R33HL147906
Status last verified: Jul 2025
First submitted: 31 Dec 2019
Last updated: 17 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual patient data related to primary outcome

Publications

Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10.
PubMed 31519441
Praca ELL, Tiller CJ, Kisling JA, Tepper RS. An alternative method to measure the diffusing capacity of the lung for carbon monoxide in infants. Pediatr Pulmonol. 2018 Mar;53(3):332-336. doi: 10.1002/ppul.23926. Epub 2017 Dec 19.
PubMed 29265767
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
Mamidi RR, Go MDA, Harris J, Olson M, Milner K, Tepper RS, Morris C, Park B, Schelonka R, MacDonald KD, McEvoy CT. Extended Continuous Positive Airway Pressure in Infants Born Preterm Decreases Intermittent Hypoxemia: A Secondary Analysis of a Randomized Controlled Trial. J Pediatr. 2026 May 25;296:115165. doi: 10.1016/j.jpeds.2026.115165. Online ahead of print.
PubMed 42190903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neonatal trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04295564
Acronym / sponsor ID: eCPAP
Conditions: Neonatal, Premature Birth, Respiratory Distress Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Cynthia McEvoyUniversity, hospital or other
Collaborators: Indiana University, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 10 Jan 2020 (actual)
Primary completion: 18 Sep 2023 (actual)
Study completion: 15 Mar 2024 (actual)
First posted: 4 Mar 2020 (actual)
Results: Posted 17 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
eCPAP	Experimental	Other: Additional 2 weeks of CPAPParticipants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.
dCPAP	No intervention	–Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

Who may qualify

Ages: 1 day to 12 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Infants born at >24 to ≤ 32 weeks gestation
Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)

Key exclusion criteria (10 listed)

Significant congenital heart disease
Major malformations
Chromosomal anomalies
Culture proven sepsis at consent
Complex maternal medical conditions

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
Additional 2 weeks of CPAPSubjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.	Other	eCPAP

Primary outcome

Alveolar Volume
Time frame: 4 - 8 months of age
Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin.

2 secondary outcomes

Lung Diffusion
Time frame: 4 - 8 months of age
Forced Expiratory Flows at 50% of the Expired Volume (FEF50)
Time frame: 4 - 8 months of age

Results and safety

Results posted to the registry on 17 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extended Continuous Positive Airway Pressure (eCPAP)	54	53
Discontinue Continuous Positive Airway Pressure (dCPAP)	46	46

Primary outcome: Alveolar Volume

Time frame: 4 - 8 months of age. Mean (Standard Error). Unit: mL

Measure	eCPAP n = 47	dCPAP n = 46
Value	500.2 (24.9)	418.1 (23.4)

eCPAP vs dCPAP: Mean Difference (Final Values): 82.1 (95% CI 8.3 to 155.9), p <0.05, Mixed Models Analysis

Population analysed: Decrease in the number of participants analyzed versus those initially randomized due to: Seven infants in the eCPAP arm did not complete VA testing due to the following reasons: 1 diagnosed with ARID1B mutation diagnosed after discharge and discontinued from study by the principal investigator; 1 with seizure disorder so could not be sedated; 3 mothers (one with a set of twins) refused sedation for the outpatient test; 1 infant with a technically unacceptable test.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From consent through 12 months of age.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eCPAP	1 of 54 (1.9%)	37 of 54 (68.5%)	0 of 54
dCPAP	1 of 46 (2.2%)	29 of 46 (63%)	0 of 46

Limitations and caveats (from the sponsor): Single center randomized controlled trial which may limit generalizability. Testing required mild sedation. Testing equipment is not commercially available. The study did not include preterm infants with the most severe respiratory disease. The clinical outcome of wheeze was obtained by parental report rather than assessment by medical personnel, which may have affected the accuracy of the wheeze outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31519441Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10.
Background: PubMed 29265767Praca ELL, Tiller CJ, Kisling JA, Tepper RS. An alternative method to measure the diffusing capacity of the lung for carbon monoxide in infants. Pediatr Pulmonol. 2018 Mar;53(3):332-336. doi: 10.1002/ppul.23926. Epub 2017 Dec 19.
Results publication: 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.
Derived from this study: PubMed 42190903Mamidi RR, Go MDA, Harris J, Olson M, Milner K, Tepper RS, Morris C, Park B, Schelonka R, MacDonald KD, McEvoy CT. Extended Continuous Positive Airway Pressure in Infants Born Preterm Decreases Intermittent Hypoxemia: A Secondary Analysis of a Randomized Controlled Trial. J Pediatr. 2026 May 25;296:115165. doi: 10.1016/j.jpeds.2026.115165. Online ahead of print.
Individual participant dataSharing planned: Yes. Deidentified individual patient data related to primary outcome

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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. This study is not recruiting at the moment.

Cindy McEvoy, MD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Additional 2 weeks of CPAP in people with Neonatal and Premature Birth, run by Cynthia McEvoy 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 17 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alveolar Volume (time frame: 4 - 8 months of age). 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 NCT04295564, which also lists 4 linked publications.

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 17 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.