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Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
NCT05336890 · Ann & Robert H Lurie Children's Hospital of Chicago
In plain English
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About this study
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 unclear, and improvements in neonatal care have not improved these outcomes. While early detection and intervention can reduce the burden of these outcomes, methods for early identification of infants destined for these morbidities is currently lacking. Utilizing the Pre-Vent cohort to investigate potential underlying causes and identify predictors for these conditions as we propose here is essential to inform future prevention and intervention strategies that promote optimal health and development.
Recent compelling data indicate that early postnatal intermittent hypoxemia (IH) events may play a role in undesirable outcomes. Early postnatal IH events in extremely preterm infants are associated with bronchopulmonary dysplasia (BPD), asthma medication at 2 years, and NDI at 18 months. The ability of IH to perturb maturation of long-term respiratory control has been demonstrated in neonatal rodents consistent with preterm infants being at heightened risk for childhood SDB. Although evidence is emerging that IH events are linked to poor outcomes in premature infants, the specific relationship between distinct IH patterns (e.g. duration, timing, frequency, and nadir) and longer-term respiratory and neurologic function remains to be elucidated.
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* Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason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.
Study design
Enrollment target: 500 participants
Age groups: child
Timeline
Starts: 2022-11-01
Estimated completion: 2026-06-30
Last updated: 2024-12-05
Primary outcomes
- • Asthma (5 years ± 6 months of age)
- • Sleep Disordered Breathing (SDB) (5 years ± 6 months of age)
- • Neurodevelopmental Impairment (NDI) (5 years ± 6 months of age)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · other
With: University of Virginia, Case Western Reserve University, University of Miami, Northwestern University, National Heart, Lung, and Blood Institute (NHLBI), University of Alabama at Birmingham
Contacts & investigators
ContactErin Smith Lonergan · contact · ersmith@luriechildrens.org · 312-227-3300
ContactCasey Rand · contact · crand@luriechildrens.org · 312-227-3300
InvestigatorDebra Weese-Mayer, MD · principal_investigator, Ann & Robert H Lurie Children's Hospital of Chicago
InvestigatorAnna Maria Hibbs, MD · principal_investigator, Case Western Reserve University
InvestigatorAmbalavanan Namasivayam, MD · principal_investigator, University of Alabama at Birmingham
All locations (1)
Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
Chicago, Illinois, United States