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

NCT05336890 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER
  • Case Western Reserve University

    collaborator OTHER
  • University of Miami

    collaborator OTHER
  • Northwestern University

    collaborator OTHER
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Alabama at Birmingham

    collaborator OTHER
  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Debra Weese-Mayer, MD · Ann & Robert H Lurie Children's Hospital of Chicago

  • Anna Maria Hibbs, MD · Case Western Reserve University

  • Ambalavanan Namasivayam, MD · University of Alabama at Birmingham

  • Nelson Claure, MSc, PhD · University of Miami

  • Randall Moorman, MD · University of Virginia

Eligibility

Min Age
30 Weeks
Max Age
83 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05336890 on ClinicalTrials.gov