eCPAP Follow-up at School Age
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
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Cynthia McEvoy, MD, MCR
- Telefonnummer: 503-494-0085
- E-post: mcevoyc@ohsu.edu
Studer Kontakt Backup
- Navn: Kristin Milner, CMA, BS, CCRP
- Telefonnummer: 971-278-3345
- E-post: milner@ohsu.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
This is an observational follow-up study of former preterm infants who participated in the randomized clinical trial extended CPAP "parent study."
Beskrivelse
Inclusion Criteria:
- Children randomized in the parent study
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
eCPAP
Group that was assigned to Extended CPAP (eCPAP) |
Assigned to two extra weeks of CPAP
Andre navn:
|
|
dCPAP
Group that was assigned to discontinue CPAP (dCPAP) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sustained improvement of lung function (functional outcomes)
Tidsramme: 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. |
Between the ages of 6 and 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Airway tree changes (structural outcomes)
Tidsramme: 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. |
Between the ages of 6 and 8
|
|
Molecular Endotypes
Tidsramme: 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). |
Between the ages of 7 and 8
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cynthia McEvoy, MD, MCR, Oregon Health and Science University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00030307
- 1R01HL184382-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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