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New study aims to help detect sepsis in newborns faster

NCT ID NCT03623503

Knowledge-focused Sponsor: Centre Hospitalier Universitaire, Amiens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 58 full-term newborns with suspected early-onset sepsis to find early clinical signs that could help doctors tell if a bacterial infection is present. Researchers reviewed medical records from 2013 at a single hospital. The goal was to improve diagnosis and avoid unnecessary treatments.

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 help doctors diagnose newborn sepsis earlier and more accurately, potentially reducing unnecessary antibiotic use.
What could go wrong
This was a small, single-center, retrospective study. The findings may not apply to all newborns or hospitals, and more research is needed to confirm the results.

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

58 people

The number who actually took part.

Started

Feb 2016

Finished

Jul 2017

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

Children born between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs. Presence of early clinical signs, ie before 72 hours of life.

Ages

1 day and older

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: * Children born at the University Hospital Center in Amiens between 1 January and 31 December 2013 and hospitalized in the neonatology department for suspicion of MFIs Exclusion Criteria: * Child born before 37 weeks of amenorrhea and / or having a failure in the birth room requiring immediate transfer to neonatal resuscitation or intensive care neonatology

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

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

Newborn sepsis

Contacts and locations

Locations

  • CHU Amiens-Picardie

    Amiens, 80054, France

More trials for these conditions

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