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Can a Preemie's NICU breathing pattern predict asthma and sleep problems years later?

NCT ID NCT05336890

Knowledge-focused Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers want to know if breathing patterns recorded while premature babies are in the neonatal intensive care unit relate to asthma, sleep-disordered breathing, and neurodevelopmental problems at preschool age. The study follows up to 500 children born before 29 weeks of pregnancy who took part in an earlier Pre-Vent study. By comparing NICU breathing data with health questionnaires and developmental tests at ages 3 to 7, the team aims to build a personalized tool for spotting which children need early help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the link holds, doctors could use NICU breathing records to flag which premature babies need early monitoring for asthma, sleep problems, or developmental delays.
What could go wrong
This is an observational study, so it can show associations but not prove cause and effect. The findings may not apply to premature infants born after 29 weeks or to those without detailed NICU breathing data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

30 weeks to 83 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

childhood onset asthma neurodevelopmental disorder Premature Birth sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma in children Neurodevelopmental disorders Premature birth Sleep disordered breathing

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Chicago, Illinois, 60611, United States

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