Clinical Trial

Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age

Recruiting

Record status

This record was last updated December 5, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 5 amendments

This ClinicalTrials.gov record has been amended 5 times since 2022-04-14; most recent amendment 2024-12-03.

Status change: Not Yet Recruiting → Recruiting 2023-02-06

Trial Details

NCT Number	NCT05336890
Lead Sponsor	Ann & Robert H Lurie Children's Hospital of Chicago Collaborators: University of Virginia, Case Western Reserve University, University of Miami, Northwestern University, National Heart, Lung, and Blood Institute (NHLBI), University of Alabama at Birmingham
Conditions	Premature Birth, Asthma in Children, Sleep-Disordered Breathing, Neurodevelopmental Disorders
Enrollment	500 participants
Start Date	2022-11-01
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-12-05