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Newborn infection risk detected in hours with Light-Based score

NCT ID NCT07109856

Diagnosis Sponsor: Medical University of Graz 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new, non-invasive tool called the POP-Score to predict infection in newborns within the first 6 hours of life. The score combines light-based measurements of muscle oxygen with routine vital signs like heart rate and blood pressure. Researchers will enroll 93 newborns with breathing problems to see if the score can accurately predict elevated infection markers within 48 hours.

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 could give doctors a simple, non-invasive way to spot infections in newborns hours earlier than current methods.
What could go wrong
This is a small, early-phase study at one hospital. The score may not work as well in larger, more diverse groups or in real-world settings.

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 93 people

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

Started

Nov 2025

Expected to finish

May 2028

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

Term and moderate-to-late preterm neonates (birth weight ≥ 2000 grams) with signs of respiratory distress within the first 6 hours after birth, admitted to the neonatal intensive care unit at the Medical University of Graz. All participants must have a gestational age allowing for clinical stability and must meet inclusion criteria including full life support decision and informed consent obtained within 6 hours of birth.

Ages

0 to 6 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: * birth weight ≥ 2000 grams * Signs of respiratory distress at time-point of inclusion (tachypnoea \>60/min, grunting, intercostal/subcostal/jugular retractions, nasal flaring, supplemental oxygen or respiratory support) * Decision to conduct full life support * Written informed consent obtained within the first 6 hours after birth, before inclusion in the study * Age \< 6 hours Exclusion Criteria: * No decision to conduct full life support * No written informed consent * Birth weight \< 2000 grams * Age \> 6 hours * Severe congenital malformations, * Umbilical cord artery pH \<7.20

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Conditions

The condition(s) this trial relates to.

Infections infectious disease neonatal sepsis Premature Birth

As listed by the trial registrant

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

Infection Near-infrared spectroscopy Neonatal sepsis, early-onset NIRS Prematurity, infections Preterm neonates Term infant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

  • Medical University of Graz, Division of Neonatology

    RECRUITING

    Graz, Styria, 8036, Austria

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