New blood test could slash unnecessary antibiotics in sick newborns
NCT ID NCT03299751
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This study tested whether a combination of 11 blood markers can more accurately diagnose late-onset sepsis in newborns in the NICU. Current methods are slow and often lead to unnecessary antibiotic use. Researchers enrolled 233 newborns with signs of infection to see if this biomarker panel could quickly rule out sepsis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- biomarker combination (11 blood markers)
- What this could lead to
- If successful, this could provide a faster, more reliable way to rule out sepsis in newborns, reducing unnecessary antibiotic use and its complications.
- What could go wrong
- This is a completed diagnostic study, not a treatment trial. The biomarker combination may not prove accurate enough in real-world settings or for all newborns.
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
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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
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233 people
The number who actually took part.
- Started
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Nov 2017
- Finished
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Nov 2020
- Lead sponsor
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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
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7 days and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * patients hospitalized in NICU; * patients with suggestive signs of LOS including at least one of the following: o Fever \> 38°C; tachycardia \> 160bpm160 bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome,; bloating; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; * patients with a standard of care blood sampling, including at least a blood culture; * consent form signed by at least one parent/ legal representative. Exclusion Criteria: * patients treated with antibiotics for a bacteriologically confirmed infection at the moment of/ or 48 hours before blood sampling * patients who underwent surgery during the 7 days prior to inclusion * patients vaccinated during the 7 days prior to inclusion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU de Nantes
Nantes, France
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Hospices Civils de Lyon
Bron, 69500, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.