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NCT Number: NCT05336890

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

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.

Recruiting

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Key information

Age range

30 week–83 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Casey Rand

CONTACT

Erin Lonergan, RRT, MS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Asthma

    Time frame: 5 years ± 6 months of age

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

  2. Sleep Disordered Breathing (SDB)

    Time frame: 5 years ± 6 months of age

    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.

  3. Neurodevelopmental Impairment (NDI)

    Time frame: 5 years ± 6 months of age

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

Secondary outcomes

  1. Respiratory Symptoms

    Time frame: 5 yr. (+/- 6 months)

    Respiratory Symptoms reported on the ISAAC Questionnaire

  2. Medically attended respiratory illnesses

    Time frame: 5 yr. (+/- 6 months)

    Medically attended respiratory illnesses in the past year by ISAAC questionnaire

  3. Asthma Severity

    Time frame: 5 yr. (+/- 6 months)

    Asthma Severity by Modified Composite Asthma Severity Score (MCASI). Minimum value = 0. Max value = 21. Higher scores mean a worse outcome.

  4. Sleep Disordered Breathing (SDB)

    Time frame: 5 yr. (+/- 6 months)

    Score on SDB questionnaire. Scores >0.33 are considered positive and suggestive of high-risk for a pediatric sleep-related breathing disorder.

  5. Motor Function

    Time frame: 5 yr. (+/- 6 months)

    Motor Function based on NIH Toolbox Motor Battery

  6. Gross Motor Function

    Time frame: 5 yr. (+/- 6 months)

    Motor Function based on Gross Motor Functional Classification System

  7. Cognitive Function

    Time frame: 5 yr. (+/- 6 months)

    Cognitive Function based on NIH Toolbox Cognitive Battery

  8. Executive Function

    Time frame: 5 yr. (+/- 6 months)

    Executive Function based on Behavior rating inventory of executive function

  9. Social, Emotional and Behavioral Outcomes

    Time frame: 5 yr. (+/- 6 months)

    Social, Emotional and Behavioral Outcomes based on NIH Toolbox Parent Proxy Emotion Battery

  10. Sensory Outcomes: Odor Identification

    Time frame: 5 yr. (+/- 6 months)

    Sensory Outcomes based on NIH Toolbox Odor Identification Test

  11. Sensory Outcomes: Acuity

    Time frame: 5 yr. (+/- 6 months)

    Sensory Outcomes based on NIH Toolbox Visual Acuity Test

  12. Pediatric Quality of life

    Time frame: 5 yr. (+/- 6 months)

    Quality of life as assessed by the Pediatric Quality of Life parent proxy questionnaire

  13. Health utilization

    Time frame: 5 yr. (+/- 6 months)

    Health utilization, based on broad health parent questionnaire

  14. Medications

    Time frame: 5 yr. (+/- 6 months)

    Medications based on broad health parent questionnaire

  15. Doctor Diagnosed Asthma

    Time frame: 6 mo through 5 yr. +6 months

    Doctor Diagnosed Asthma based on ISAAC

  16. Respiratory Symptoms

    Time frame: 6 mo through 5 yr. +6 months

    Respiratory Symptoms based on ISAAC

  17. Medically attended respiratory illnesses

    Time frame: 6 mo through 5 yr. +6 months

    Medically attended respiratory illnesses in past year based on broad health parent questionnaire

  18. Asthma Severity: Modified Composite Asthma Severity Index(MCASI)

    Time frame: 6 mo through 5 yr. +6 months

    Asthma Severity by MCASI score. Minimum value = 0. Max value = 21. Higher scores mean a worse outcome.

  19. Asthma Severity: Global Initiative for Asthma criteria (GINA)

    Time frame: 6 mo through 5 yr. +6 months

    Asthma Severity using GINA criteria based on broad health parent questionnaire. A score of 19 or less indicates poorly controlled asthma, while a score greater than 19 indicates well-controlled asthma.

  20. Health utilization

    Time frame: 6 mo through 5 yr. +6 months

    Health utilization, based on parent broad health questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Casey Rand

CONTACT

[email protected]

312-227-3300

Erin Smith Lonergan

CONTACT

[email protected]

312-227-3300

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • Case Western Reserve University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Northwestern University
  • University of Alabama at Birmingham
  • University of Miami
  • University of Virginia

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2022
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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