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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05336890
Other study ID # HSR210359
Secondary ID 1R01HL157256-01A
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date June 30, 2026

Study information

Verified date August 2023
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Erin Smith Lonergan
Phone 312-227-3300
Email ersmith@luriechildrens.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

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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