RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05336890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Weeks to 83 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Born \<29 weeks gestational age
  3. * Age at enrollment less than 7 years old
  1. * Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
  2. * Subject had no physiological data recorded as part of Pre-Vent
  3. * Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
  4. * Adopted by non-consenting family
  5. * Parent refused further contact, prior to approach for Post-Vent
  6. * Infant enrolled in Pre-Vent at Washington University St Louis, which is not a Post-Vent participating site.

Contacts and Locations

Study Contact

Erin Smith Lonergan
CONTACT
312-227-3300
ersmith@luriechildrens.org
Casey Rand
CONTACT
312-227-3300
crand@luriechildrens.org

Principal Investigator

Debra Weese-Mayer, MD
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Anna Maria Hibbs, MD
PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Ambalavanan Namasivayam, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Nelson Claure, MSc, PhD
PRINCIPAL_INVESTIGATOR
University of Miami
Randall Moorman, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

  • Debra Weese-Mayer, MD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago
  • Anna Maria Hibbs, MD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University
  • Ambalavanan Namasivayam, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham
  • Nelson Claure, MSc, PhD, PRINCIPAL_INVESTIGATOR, University of Miami
  • Randall Moorman, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Premature Birth
  • Asthma in Children
  • Sleep-Disordered Breathing
  • Neurodevelopmental Disorders