Actively Recruiting
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-12-05
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
U
University of Virginia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the long-term effects of premature birth on children, focusing on asthma, sleep-disordered breathing (SDB), and neurodevelopmental impairments (NDI). These conditions are common among extremely premature infants and can significantly affect quality of life. The study aims to understand if certain breathing patterns experienced by babies while in the neonatal intensive care unit (NICU) are linked to these health issues. The research seeks to improve early detection and intervention by identifying predictors of these outcomes. This observational study uses data from the Pre-Vent cohort to explore how intermittent hypoxemia (IH) events—periods of low oxygen levels in the blood—may relate to these conditions. It examines the patterns of IH, including duration, timing, frequency, and severity, to clarify their impact on long-term respiratory and neurological health. The study focuses on children born before 29 weeks gestational age and assesses them around preschool age, up to 7 years old. Participants will be evaluated around 5 years of age, plus or minus 6 months, to measure asthma, sleep-disordered breathing, and neurodevelopmental outcomes. Researchers will collect information on respiratory symptoms, motor and cognitive functions, behavioral health, sensory abilities, quality of life, medication use, and healthcare utilization. The study involves reviewing medical histories and assessments to better understand the links between early breathing patterns and later health effects, with safety monitoring and follow-up extending until the child reaches about 7 years old.
CONDITIONS
Brief Title
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in any Institutional Review Board protocol of the Pre-Vent Study with signed consent or authorized re-contact for future research
- Born before 29 weeks gestational age
- Age at enrollment less than 7 years old
You will not qualify if you...
- Withdrawn from the Pre-Vent study after signing consent for any reason
- No physiological data recorded as part of Pre-Vent
- Lack of regulatory approval to recontact subjects
- Adopted by a non-consenting family
- Parent refused further contact before Post-Vent approach
- Infant enrolled in Pre-Vent at Washington University St Louis, a non-participating site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo assessments to evaluate respiratory and neurodevelopmental function at preschool age.
1 visit (in-person)
Duration - Approximately 5 years
Participants are observed for respiratory symptoms, asthma severity, motor and cognitive functions, and quality of life outcomes from 6 months through 5 years of age.
Assessments occur at or around 5 years of age with additional data collected from medical records between 6 months and 5 years
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
E
Erin Smith Lonergan
C
Casey Rand
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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