Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Recruiting · NCT05336890 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason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
1 location listed across 1 US state.
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago, Illinois, United States