eCPAP Follow-up at School Age

NCT07860931 — Not yet recruiting, 95 participants, Cynthia McEvoy

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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

RegistryNCT07860931
StatusNot yet recruiting
Study typeObservational
Enrollment95 (Estimated)
SponsorCynthia McEvoy (Other); collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Indiana University
ConditionsLung Function
InterventionsExtended CPAP (eCPAP) (Other)
Datesstart 2026-10-01 (estimated), primary completion 2032-12-01 (estimated), completion 2033-12-01 (estimated), first posted 2026-10-06, last updated 2026-10-08

Related Papers Related Patents Related Grants Related Experts
All trials for Lung Function All trials of Extended CPAP (eCPAP)

-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 children.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
eCPAPOther: Extended CPAP (eCPAP)Group that was assigned to Extended CPAP (eCPAP)
dCPAPGroup that was assigned to discontinue CPAP (dCPAP)
  • Extended CPAP (eCPAP) (Other), also known as Treatment length: Assigned to two extra weeks of CPAP

+Outcome measures

Primary outcomes

  • Sustained improvement of lung function (functional outcomes) [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.

Secondary outcomes

  • Airway tree changes (structural outcomes) [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.
  • Molecular Endotypes [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).

+Eligibility

Sex: All

Inclusion Criteria:

* Children randomized in the parent study

Exclusion Criteria:

* None

+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. PMID 39977011

+Investigators

+Funding

NIH grants: R01HL184382