NCT05336890 Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
| NCT ID | NCT05336890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Condition | Premature Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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29 weeks gestational age * Age at enrollment less than 7 years old Exclusion Criteria: * Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason * Subject had no physiological data recorded as part of Pre-Vent * Lack of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.
Contact & Investigator
Debra Weese-Mayer, MD
PRINCIPAL INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Frequently Asked Questions
Who can join the NCT05336890 clinical trial?
This trial is open to participants of all sexes, aged 30 Weeks or older, up to 83 Months, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05336890 currently recruiting?
Yes, NCT05336890 is actively recruiting participants. Contact the research team at ersmith@luriechildrens.org for enrollment information.
Where is the NCT05336890 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05336890 clinical trial?
NCT05336890 is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. The principal investigator is Debra Weese-Mayer, MD at Ann & Robert H Lurie Children's Hospital of Chicago. The trial plans to enroll 500 participants.