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

NCT04295564 | Completed Results DMC

• 2 other identifiers: eCPAPR33HL147906
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal; Premature Birth; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  4 - 8 months of age

Secondary Outcomes (2)

• Lung Diffusion

  4 - 8 months of age

• Forced Expiratory Flows at 50% of the Expired Volume (FEF50)

  4 - 8 months of age

Other Outcomes (2)

• Number of Participants With the Occurrence of Wheeze

  through 12 months of age (+/- 2 months)

• Bayley III Gross Motor Scores

  through 12 months of age (+/- 2 months)

Study Arms (2)

eCPAP

EXPERIMENTAL

Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met.

Other: Additional 2 weeks of CPAP

dCPAP

NO INTERVENTION

Participants will discontinue CPAP as per usual care once CPAP stability criteria is met.

Interventions

Additional 2 weeks of CPAP OTHER

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

eCPAP

Eligibility Criteria

• Age: 1 Day - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cynthia McEvoy: lead
• Indiana University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Doernbecher Neonatal Care Center at Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• 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.

  PMID: 31519441 BACKGROUND

• 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.

  PMID: 29265767 BACKGROUND

• 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.

  PMID: 39977011 RESULT

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Cindy McEvoy
• Organization: OHSU

mcevoyc@ohsu.edu

503-494-0223

Study Officials

• Cindy McEvoy, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: March 4, 2020
• Study Start: January 10, 2020
• Primary Completion: September 18, 2023
• Study Completion: March 15, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year after publication of primary paper, lasting for 5 years.
• Access Criteria: Signed data access agreement

Locations

US (1)