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

NCT05336890 | Recruiting DMC

• 2 other identifiers: HSR2103591R01HL157256-01A1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Asthma

  Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC)

  5 years ± 6 months of age

• Sleep Disordered Breathing (SDB)

  Sleep-Related Breathing Disorder (SRBD) score \>= 0.33. Scores \>0.33 are considered positive and suggestive of high-risk for a pediatric sleep-related breathing disorder.

  5 years ± 6 months of age

• Neurodevelopmental Impairment (NDI)

  ≤10th percentile in any of the National Institutes of Health (NIH) Toolbox domains may indicate neurodevelopmental impairment.

  5 years ± 6 months of age

Secondary Outcomes (20)

• Respiratory Symptoms

  5 yr. (+/- 6 months)

• Medically attended respiratory illnesses

  5 yr. (+/- 6 months)

• Asthma Severity

  5 yr. (+/- 6 months)

• Sleep Disordered Breathing (SDB)

  5 yr. (+/- 6 months)

• Motor Function

  5 yr. (+/- 6 months)

Eligibility Criteria

• Age: 30 Weeks - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from surviving, previously consented children in the existing Pre-Vent study cohort or in any IRB protocol of the Pre-Vent study that authorized re-contact for future research, which was drawn from Neonatal Intensive Care Unit Populations in Chicago, IL; Cleveland, OH; Birmingham, AB; or Miami, FL, USA. Up to 500 children will be enrolled after parent/guardian provides informed consent. Parents, guardians or primary caretakers will act as proxies for providing information about the children.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• University of Virginia: collaborator
• Case Western Reserve University: collaborator
• University of Miami: collaborator
• Northwestern University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

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

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Sleep Apnea Syndromes; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Debra Weese-Mayer, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Anna Maria Hibbs, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Ambalavanan Namasivayam, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Nelson Claure, MSc, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Randall Moorman, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Smith Lonergan

CONTACT

312-227-3300; ersmith@luriechildrens.org

Casey Rand

CONTACT

312-227-3300; crand@luriechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)