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Premature BirthNCT05336890

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

An observational study of Premature Birth and Asthma in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 30 weeks to 83 months
How many people
500 participants
Where
1 siteUnited States
Study dates
1 Nov 2022to 30 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 weeks to 83 months
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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

Who cannot join

  • Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Erin Smith Lonergan contact

312-227-3300

ersmith@luriechildrens.org

Casey Rand contact

312-227-3300

crand@luriechildrens.org

United States1 site, 1 recruiting

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

    Chicago, Illinois, 60611

    Erin Lonergan, RRT, MS

    Casey Rand

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Premature Birth, Sleep Apnea Syndromes, Neurodevelopmental Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma

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

    Measured: 5 years ± 6 months of age

  2. 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.

    Measured: 5 years ± 6 months of age

  3. Neurodevelopmental Impairment (NDI)

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

    Measured: 5 years ± 6 months of age

Secondary outcomes (20)

  1. Respiratory Symptoms

    Respiratory Symptoms reported on the ISAAC Questionnaire

    Measured: 5 yr. (+/- 6 months)

  2. Medically attended respiratory illnesses

    Medically attended respiratory illnesses in the past year by ISAAC questionnaire

    Measured: 5 yr. (+/- 6 months)

  3. Asthma Severity

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

    Measured: 5 yr. (+/- 6 months)

  4. Sleep Disordered Breathing (SDB)

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

    Measured: 5 yr. (+/- 6 months)

  5. Motor Function

    Motor Function based on NIH Toolbox Motor Battery

    Measured: 5 yr. (+/- 6 months)

  6. Gross Motor Function

    Motor Function based on Gross Motor Functional Classification System

    Measured: 5 yr. (+/- 6 months)

  7. Cognitive Function

    Cognitive Function based on NIH Toolbox Cognitive Battery

    Measured: 5 yr. (+/- 6 months)

  8. Executive Function

    Executive Function based on Behavior rating inventory of executive function

    Measured: 5 yr. (+/- 6 months)

  9. Social, Emotional and Behavioral Outcomes

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

    Measured: 5 yr. (+/- 6 months)

  10. Sensory Outcomes: Odor Identification

    Sensory Outcomes based on NIH Toolbox Odor Identification Test

    Measured: 5 yr. (+/- 6 months)

  11. Sensory Outcomes: Acuity

    Sensory Outcomes based on NIH Toolbox Visual Acuity Test

    Measured: 5 yr. (+/- 6 months)

  12. Pediatric Quality of life

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

    Measured: 5 yr. (+/- 6 months)

  13. Health utilization

    Health utilization, based on broad health parent questionnaire

    Measured: 5 yr. (+/- 6 months)

  14. Medications

    Medications based on broad health parent questionnaire

    Measured: 5 yr. (+/- 6 months)

  15. Doctor Diagnosed Asthma

    Doctor Diagnosed Asthma based on ISAAC

    Measured: 6 mo through 5 yr. +6 months

  16. Respiratory Symptoms

    Respiratory Symptoms based on ISAAC

    Measured: 6 mo through 5 yr. +6 months

  17. Medically attended respiratory illnesses

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

    Measured: 6 mo through 5 yr. +6 months

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

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

    Measured: 6 mo through 5 yr. +6 months

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

    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.

    Measured: 6 mo through 5 yr. +6 months

  20. Health utilization

    Health utilization, based on parent broad health questionnaire

    Measured: 6 mo through 5 yr. +6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336890
Sponsor's protocol ID
HSR210359
Other IDs
1R01HL157256-01A1
Status last verified
Sep 2026
First submitted
14 Apr 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Premature Birth and Asthma in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erin Smith Lonergan (312-227-3300, ersmith@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma (time frame: 5 years ± 6 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05336890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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