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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336890
• Other study ID #: HSR210359
• Secondary ID: 1R01HL157256-01A
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Erin Smith Lonergan
• Phone: 312-227-3300
• Email: ersmith[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 66 Months

Eligibility

Inclusion Criteria:

• Enrolled in any 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 or equal to 60 +6 months

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 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma	Doctor diagnosed asthma as assessed in the International Study on Asthma and Allergies in Childhood questionnaire (ISAAC)	5 years ± 6 months of age
Primary	Sleep Disordered Breathing (SDB)	Sleep-Related Breathing Disorder (SRBD) score >= 0.33	5 years ± 6 months of age
Primary	Neurodevelopmental Impairment (NDI)	=10th percentile in any of the National Institutes of Health (NIH) Toolbox domains	5 years ± 6 months of age
Secondary	Respiratory Symptoms by ISAAC Questionnaire		5 yr. (+/- 6 months)
Secondary	Medically attended respiratory illnesses		5 yr. (+/- 6 months)
Secondary	Asthma Severity by Modified Composite Asthma Severity Score (MCASI)		5 yr. (+/- 6 months)
Secondary	SDB: by SRBD score as Continuous variable		5 yr. (+/- 6 months)
Secondary	Motor Function based on NIH Toolbox Motor Battery		5 yr. (+/- 6 months)
Secondary	Motor Function based on Gross Motor Functional Classification System		5 yr. (+/- 6 months)
Secondary	Cognitive Function based on NIH Toolbox Cognitive Battery		5 yr. (+/- 6 months)
Secondary	Executive Function based on Behavior rating inventory of executive function		5 yr. (+/- 6 months)
Secondary	Social, Emotional and Behavioral Outcomes based on NIH Toolbox Parent Proxy Emotion Battery		5 yr. (+/- 6 months)
Secondary	Sensory Outcomes based on NIH Toolbox Odor Identification Test		5 yr. (+/- 6 months)
Secondary	Sensory Outcomes based on NIH Toolbox Visual Acuity Test		5 yr. (+/- 6 months)
Secondary	Quality of life as assessed by the Pediatric Quality of Life questionnaire		5 yr. (+/- 6 months)
Secondary	Asthma Severity using Global Initiative for Asthma (GINA) criteria, based on parent questionnaire		5 yr. (+/- 6 months)
Secondary	Health utilization, based on parent questionnaire		5 yr. (+/- 6 months)
Secondary	Medications, based on parent questionnaire		5 yr. (+/- 6 months)
Secondary	Medications, based on parent questionnaire		6 mo through 5 yr. +6 months
Secondary	Doctor Diagnosed Asthma based on ISAAC		6 mo through 5 yr. +6 months
Secondary	Respiratory Symptoms based on ISAAC		6 mo through 5 yr. +6 months
Secondary	Medically attended respiratory illnesses in past year		6 mo through 5 yr. +6 months
Secondary	Asthma Severity by MCASI		6 mo through 5 yr. +6 months
Secondary	Asthma Severity using GINA criteria		6 mo through 5 yr. +6 months
Secondary	Health utilization, based on parent questionnaire		6 mo through 5 yr. +6 months