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New Light-Based test aims to catch deadly newborn gut disease early

NCT ID NCT01833000

Diagnosis Sponsor: University Hospital, Montpellier 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at whether measuring oxygen levels in the brain and gut using a light-based device (NIRS) could help doctors diagnose necrotizing enterocolitis (NEC) earlier in newborns with symptoms like bloody stool or a swollen belly. The study planned to include 45 newborns under 28 days old. However, the study was stopped early, so results are limited.

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

45 people

The number who actually took part.

Started

Feb 2013

Finished

Mar 2016

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

Up to 28 days

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: * less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension * signed authorization by the parents (consent form) Exclusion Criteria: * \- cutaneous lesions in the regions of monitoring * emergency for NEC

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Conditions

The condition(s) this trial relates to.

Gastrointestinal Hemorrhage necrotizing enterocolitis

As listed by the trial registrant

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

Necrotizing enterolitis

Contacts and locations

Locations

  • University Hospital of Montpellier

    Montpellier, 34295, France