Clinical trial NCT05336890: Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Official title: Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Birth
Asthma in Children
Sleep-Disordered Breathing
Neurodevelopmental Disorders
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Case Western Reserve University
name: University of Miami
name: Northwestern University
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Alabama at Birmingham
First posted: 2022-04-20
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma
timeFrame: 5 years ± 6 months of age
measure: Sleep Disordered Breathing (SDB)
timeFrame: 5 years ± 6 months of age
measure: Neurodevelopmental Impairment (NDI)
timeFrame: 5 years ± 6 months of age
Secondary outcomes:
measure: Respiratory Symptoms
timeFrame: 5 yr. (+/- 6 months)
measure: Medically attended respiratory illnesses
timeFrame: 5 yr. (+/- 6 months)
measure: Asthma Severity
timeFrame: 5 yr. (+/- 6 months)
measure: Sleep Disordered Breathing (SDB)
timeFrame: 5 yr. (+/- 6 months)
measure: Motor Function
timeFrame: 5 yr. (+/- 6 months)
measure: Gross Motor Function
timeFrame: 5 yr. (+/- 6 months)
measure: Cognitive Function
timeFrame: 5 yr. (+/- 6 months)
measure: Executive Function
timeFrame: 5 yr. (+/- 6 months)
measure: Social, Emotional and Behavioral Outcomes
timeFrame: 5 yr. (+/- 6 months)
measure: Sensory Outcomes: Odor Identification
timeFrame: 5 yr. (+/- 6 months)
measure: Sensory Outcomes: Acuity
timeFrame: 5 yr. (+/- 6 months)
measure: Pediatric Quality of life
timeFrame: 5 yr. (+/- 6 months)
measure: Health utilization
timeFrame: 5 yr. (+/- 6 months)
measure: Medications
timeFrame: 5 yr. (+/- 6 months)
measure: Doctor Diagnosed Asthma
timeFrame: 6 mo through 5 yr. +6 months
measure: Respiratory Symptoms
timeFrame: 6 mo through 5 yr. +6 months
measure: Medically attended respiratory illnesses
timeFrame: 6 mo through 5 yr. +6 months
measure: Asthma Severity: Modified Composite Asthma Severity Index(MCASI)
timeFrame: 6 mo through 5 yr. +6 months
measure: Asthma Severity: Global Initiative for Asthma criteria (GINA)
timeFrame: 6 mo through 5 yr. +6 months
measure: Health utilization
timeFrame: 6 mo through 5 yr. +6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Debra Weese-Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Anna Maria Hibbs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Ambalavanan Namasivayam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Nelson Claure, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Randall Moorman, MD
role: PRINCIPAL_INVESTIGATOR
References: