Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Recruiting now
Conditions studied: Premature Birth, Asthma in Children, Sleep-Disordered Breathing, Neurodevelopmental Disorders
In brief
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 neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking. This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.
Key facts
- Study ID
- NCT05336890
- Run by
- Ann & Robert H Lurie Children's Hospital of Chicago
- People needed
- 500
- Starts
- 2022-11-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2024-12-05
Who can join
Age: 1 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason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.
Where it is running
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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