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New study aims to uncover hidden threat of enterovirus in newborns

NCT ID NCT07356583

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking enterovirus infections in newborns across Italy, with a special focus on a dangerous strain called Echovirus 11. Researchers will analyze samples from 1,600 babies in intensive care to understand how common these infections are, what makes some cases severe, and how the virus spreads. The goal is to build a surveillance system that could help detect and respond to outbreaks faster.

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 lead to better surveillance and early detection of dangerous enterovirus strains in newborns, potentially reducing severe illness and deaths.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any therapy, and results may not change clinical practice immediately.

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 1,600 people

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

Started

Feb 2026

Expected to finish

Feb 2027

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

All neonates admitted to the neonatal intensive care unit.

Ages

1 day 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: Samples from consecutive neonates admitted to neonatal intensive care unit. Exclusion Criteria: Insufficient residual samples (volume less than 1 mL of nasal swab) will be excluded from the study

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Conditions

The condition(s) this trial relates to.

digestive system disorder enterovirus infectious disease infectious disease with sepsis Sepsis syndromic disease

As listed by the trial registrant

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

Clinical syndrome Enterovirus Gastrointestinal Respiratory complications Sepsis

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

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Lombardy, 27100, Italy

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