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New brain monitoring method may predict injury in tiniest newborns

NCT ID NCT02814383

Knowledge-focused Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study investigates whether a non-invasive brain monitoring tool can predict brain injury in extremely low birth weight infants (≤1000 grams) during their first week of life. Researchers will measure brain blood flow using ultrasound and other sensors to see if changes in perfusion signal risk for conditions like intraventricular hemorrhage. The goal is to develop an early warning system that could guide care and prevent lasting damage.

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 successful, this research could lead to a monitoring system that helps doctors detect and prevent brain injury in premature infants before it becomes irreversible.
What could go wrong
This is an observational study focused on understanding physiology, not testing a treatment. It is small (70 infants) and early-stage, so it may not directly change care.

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

70 people

The number who actually took part.

Started

Aug 2016

Finished

Sep 2025

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

Within 12 hours of life, subjects' mothers will be approached for participation in this research study. This study seeks to collect data on premature ELBW infants (less than or equal to 2.2 lbs) at high risk of developing brain injury.

Ages

0 to 12 hours

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: * Informed consent obtained from parent or legally authorized representative (LAR) * Live-born ELBW infant * Less than 12 hours of life * Birth weight 401 to 1000g * Admitted to Texas Children's Hospital (TCH) Pavilion for Women (PFW) Neonatal Intensive Care Unit (NICU) * Umbilical arterial catheter (UAC) in place Exclusion Criteria: * Complex congenital anomalies of central nervous system (CNS) * Complex chromosomal congenital anomalies * Hydrops fetalis * Poor skin integrity * Live-born but receiving only comfort care * Grade 3-4 IVH by head ultrasound (HUS) at the first ultrasound completed at or before 12 hours of life

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Conditions

The condition(s) this trial relates to.

brain injury periventricular leukomalacia Premature Birth

As listed by the trial registrant

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

Brain injury Extreme prematurity Intraventricular hemorrhage Periventricular leukomalacia

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Texas Children's Pavilion for Women

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.