NCT04295564

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

Completed NA Results posted Last updated 17 August 2025

What this trial tests

NA trial testing Additional 2 weeks of CPAP in Neonatal in 100 participants. Completed in 15 March 2024.

Timeline

10 January 2020

Primary endpoint
18 September 2023

15 March 2024

Quick facts

Lead sponsor	Cynthia McEvoy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	10 January 2020
Primary completion	18 September 2023
Estimated completion	15 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Additional 2 weeks of CPAP

Conditions studied

• Neonatal — all drugs for Neonatal →
• Premature Birth — all drugs for Premature Birth →
• Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →

Sponsor

Cynthia McEvoy — full company profile →

Who can join

Adults 1 Day to 12 Weeks, any sex, with Neonatal or Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Alveolar Volume Primary · 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

Group	Value	95% CI
eCPAP	500.2	± 24.9
dCPAP	418.1	± 23.4

Lung Diffusion Secondary · 4 - 8 months of age

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

Group	Value	95% CI
eCPAP	3.4	± 0.2
dCPAP	2.8	± 0.1

Forced Expiratory Flows at 50% of the Expired Volume (FEF50) Secondary · 4 - 8 months of age

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.

Group	Value	95% CI
eCPAP	500.6	± 18.2
dCPAP	437.9	± 17.9

Number of Participants With the Occurrence of Wheeze Secondary · through 12 months of age (+/- 2 months)

Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in lower respiratory morbidity through 12 months of age compared to infants who had CPAP discontinued, usual care. A standardized respiratory questionnaire was administered monthly through 12 months of age to ascertain this information on wheeze which was defined a priori.

Group	Value	95% CI
eCPAP	23
dCPAP	26

Adverse events — posted to ClinicalTrials.gov

Time frame: From consent through 12 months of age.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

eCPAP

Serious: 1/54 (2%)

Deaths: 0/54

dCPAP

Serious: 1/46 (2%)

Deaths: 0/46

Serious adverse events (2 terms)

Reaction	System	eCPAP	dCPAP
Vocal cord paralysis	Respiratory, thoracic and mediastinal disorders	—	—
streptococcus group B sepsis	Infections and infestations	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	eCPAP	dCPAP
Anemia of prematurity	Eye disorders	—	—
Apnea neonatal	Respiratory, thoracic and mediastinal disorders	—	—
Retinopathy of prematurity	Eye disorders	—	—
Neonatal respiratory insufficiency	Respiratory, thoracic and mediastinal disorders	—	—
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	—	—
Feeding disorder NOS	Metabolism and nutrition disorders	—	—
Nasal mucosal erythema	Skin and subcutaneous tissue disorders	—	—
Hemangioma of skin	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Vocal cord paralysis, streptococcus group B sepsis.

Data from ClinicalTrials.gov NCT04295564 adverse events section.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Extended Continuous Positive Airway Pressure in Preterm Infants Increases Lung Growth at 6 Months: A Randomized Controlled Trial.
   McEvoy CT, MacDonald KD, Go MA, Milner K, et al · · 2025 · cited 14× · PMID 39977011 · DOI 10.1164/rccm.202411-2169oc