Status:
RECRUITING
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
University of Virginia
Case Western Reserve University
Conditions:
Premature Birth
Asthma in Children
Eligibility:
All Genders
30-83 years
Brief Summary
Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and ...
Detailed Description
Asthma, SDB, and NDI are common consequences of preterm birth with significant impact on child and family quality of life and public health. To date, the mechanisms leading to these outcomes remain un...
Eligibility Criteria
Inclusion
- Enrolled in any Institutional Review Board (IRB) protocol of the Pre-Vent Study that had signed consent, or in any IRB protocol of the Pre-Vent Study that authorized re-contact for future research
- Born \<29 weeks gestational age
- Age at enrollment less than 7 years old
Exclusion
- Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
- Subject had no physiological data recorded as part of Pre-Vent
- Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
- Adopted by non-consenting family
- Parent refused further contact, prior to approach for Post-Vent
- Infant enrolled in Pre-Vent at Washington University St Louis, which is not a Post-Vent participating site.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05336890
Start Date
November 1 2022
End Date
June 30 2026
Last Update
December 5 2024
Active Locations (1)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611