Premature Birth Clinical Trial
Official title:
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Weeks to 66 Months |
Eligibility | Inclusion Criteria: - Enrolled in any 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29 weeks gestational age - Age at enrollment less than or equal to 60 +6 months Exclusion Criteria: - Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason - Subject had no physiological data recorded as part of Pre-Vent - Lack of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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | Case Western Reserve University, National Heart, Lung, and Blood Institute (NHLBI), Northwestern University, University of Alabama at Birmingham, University of Miami, University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma | Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC) | 5 years ± 6 months of age | |
Primary | Sleep Disordered Breathing (SDB) | Sleep-Related Breathing Disorder (SRBD) score >= 0.33 | 5 years ± 6 months of age | |
Primary | Neurodevelopmental Impairment (NDI) | =10th percentile in any of the National Institutes of Health (NIH) Toolbox domains | 5 years ± 6 months of age | |
Secondary | Respiratory Symptoms by ISAAC Questionnaire | 5 yr. (+/- 6 months) | ||
Secondary | Medically attended respiratory illnesses | 5 yr. (+/- 6 months) | ||
Secondary | Asthma Severity by Modified Composite Asthma Severity Score (MCASI) | 5 yr. (+/- 6 months) | ||
Secondary | SDB: by SRBD score as Continuous variable | 5 yr. (+/- 6 months) | ||
Secondary | Motor Function based on NIH Toolbox Motor Battery | 5 yr. (+/- 6 months) | ||
Secondary | Motor Function based on Gross Motor Functional Classification System | 5 yr. (+/- 6 months) | ||
Secondary | Cognitive Function based on NIH Toolbox Cognitive Battery | 5 yr. (+/- 6 months) | ||
Secondary | Executive Function based on Behavior rating inventory of executive function | 5 yr. (+/- 6 months) | ||
Secondary | Social, Emotional and Behavioral Outcomes based on NIH Toolbox Parent Proxy Emotion Battery | 5 yr. (+/- 6 months) | ||
Secondary | Sensory Outcomes based on NIH Toolbox Odor Identification Test | 5 yr. (+/- 6 months) | ||
Secondary | Sensory Outcomes based on NIH Toolbox Visual Acuity Test | 5 yr. (+/- 6 months) | ||
Secondary | Quality of life as assessed by the Pediatric Quality of Life questionnaire | 5 yr. (+/- 6 months) | ||
Secondary | Asthma Severity using Global Initiative for Asthma (GINA) criteria, based on parent questionnaire | 5 yr. (+/- 6 months) | ||
Secondary | Health utilization, based on parent questionnaire | 5 yr. (+/- 6 months) | ||
Secondary | Medications, based on parent questionnaire | 5 yr. (+/- 6 months) | ||
Secondary | Medications, based on parent questionnaire | 6 mo through 5 yr. +6 months | ||
Secondary | Doctor Diagnosed Asthma based on ISAAC | 6 mo through 5 yr. +6 months | ||
Secondary | Respiratory Symptoms based on ISAAC | 6 mo through 5 yr. +6 months | ||
Secondary | Medically attended respiratory illnesses in past year | 6 mo through 5 yr. +6 months | ||
Secondary | Asthma Severity by MCASI | 6 mo through 5 yr. +6 months | ||
Secondary | Asthma Severity using GINA criteria | 6 mo through 5 yr. +6 months | ||
Secondary | Health utilization, based on parent questionnaire | 6 mo through 5 yr. +6 months |
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