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

NCT ID: NCT05336890

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Premature Birth Asthma in Children Sleep-Disordered Breathing Neurodevelopmental Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

83 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra Weese-Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Anna Maria Hibbs, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Ambalavanan Namasivayam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Nelson Claure, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Randall Moorman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Smith Lonergan

Role: CONTACT

Phone: 312-227-3300

Email: [email protected]

Casey Rand

Role: CONTACT

Phone: 312-227-3300

Email: [email protected]

Facility Contacts

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Erin Lonergan, RRT, MS

Role: primary

Casey Rand

Role: backup

Other Identifiers

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1R01HL157256-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSR210359

Identifier Type: -

Identifier Source: org_study_id