Recruiting

Observational Study

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT05336890

Conditions

Premature Birth

Asthma in Children

Sleep-Disordered Breathing

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT05336890

Start date

Nov 1, 2022

Status verified date

Nov, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 6

Healthy Volunteers: Not accepted

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  • Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Asthma [ Time Frame: 5 years ± 6 months of age ]
  • Sleep Disordered Breathing (SDB) [ Time Frame: 5 years ± 6 months of age ]
  • Neurodevelopmental Impairment (NDI) [ Time Frame: 5 years ± 6 months of age ]

Central Contacts and Locations

Central contacts

Erin Smith Lonergan

312-227-3300ersmith@luriechildrens.org

Casey Rand

312-227-3300crand@luriechildrens.org

Locations

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

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Dec 5, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2024-12-05.