Understanding long-term effects of breathing patterns in preterm infants
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
This study looks at how breathing problems in preterm babies might affect their chances of developing asthma, sleep issues, and learning difficulties as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 30 Weeks to 83 Months |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05336890 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term consequences of neonatal intermittent hypoxemia on preterm infants, particularly focusing on conditions like asthma, sleep-disordered breathing, and neurodevelopmental disorders. By analyzing data from the Pre-Vent cohort, the study seeks to identify specific breathing patterns that may predict these outcomes. The research will explore the relationship between early postnatal hypoxemia events and later respiratory and neurological functions, with the goal of informing future prevention and intervention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at less than 29 weeks gestational age who are under 7 years old.
Not a fit: Patients who were withdrawn from the Pre-Vent study or lack physiological data recorded will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and intervention strategies for preterm infants, potentially reducing the incidence of asthma, sleep-disordered breathing, and neurodevelopmental impairments.
How similar studies have performed: While there is emerging evidence linking intermittent hypoxemia to poor outcomes in preterm infants, this specific approach to understanding the relationship between breathing patterns and long-term effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Debra Weese-Mayer, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Erin Smith Lonergan
- Email: ersmith@luriechildrens.org
- Phone: 312-227-3300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.