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Light device could spot brain trouble in tiniest newborns

NCT ID NCT04367181

Knowledge-focused Sponsor: Maria Angela Franceschini Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new, noninvasive device that uses light to monitor blood flow and oxygen in the brains of extremely premature babies. Researchers followed 100 infants born before 29 weeks to see if the device could detect problems linked to brain bleeding. The goal is to give doctors a better tool to protect these fragile newborns.

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 monitoring method could help doctors better manage brain health in premature infants and reduce the risk of bleeding in the brain.
What could go wrong
This is an early feasibility study, not a treatment trial. The device may not prove useful in practice, and results may not apply to all premature babies.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Mar 2019

Finished

May 2023

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.

Ages

0 to 72 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.

* Premature infants born at \<29 weeks GA and \<48 hrs of age. * No contraindication to DCS optical sensor placement on the scalp * No major congenital anomalies, * No Complex cyanotic congenital cardiac disease.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction intracerebral hemorrhage Premature Birth

As listed by the trial registrant

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

Extremely low birth weight Infant, small for gestational age Intracerebral hemorrhage Premature birth

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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