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eCPAP Follow-up at School Age

ConditionLung Function
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCynthia McEvoy

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children randomized in the parent study

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Extended CPAP (eCPAP)

    Other intervention

    Assigned to two extra weeks of CPAP

Treatment groups

95 Participants
are divided into 2 treatment groups
Group A: eCPAP1 intervention
Group B: dCPAP0 interventions

Trial outcomes

Primary outcomes

1

Sustained improvement of lung function (functional outcomes)

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.

Time frame
Between the ages of 6 and 8

Secondary outcomes

1

Airway tree changes (structural outcomes)

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.

Time frame
Between the ages of 6 and 8
2

Molecular Endotypes

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).

Time frame
Between the ages of 7 and 8

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cynthia McEvoy

Lead sponsor

Oregon Health and Science University

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Indiana University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: