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Kangaroo care could slash sepsis risk in tiny newborns

NCT ID NCT05993442

Prevention Sponsor: PENTA Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether increasing kangaroo care (skin-to-skin contact) in neonatal intensive care units can reduce severe infections and antibiotic-resistant bacteria in very premature infants (born before 32 weeks). Over 3,000 babies across multiple hospitals will be involved. The goal is to see if a simple, low-tech intervention can make a big difference in preventing hospital-acquired infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
optimised kangaroo care (skin-to-skin contact)
What this could lead to
If it works, this could provide a simple, low-cost way to prevent life-threatening infections in vulnerable premature babies.
What could go wrong
This is a large trial, but kangaroo care is already standard in many settings; the benefit may be modest or hard to implement consistently across units.

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

About 3,080 people

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

Started

May 2024

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 32 weeks

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 1\. Site level 1a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation). 1b. Minimum capacity of 12 beds. 1c. Access to a -70 to -80°C freezer for storage of research samples 1d. Willing to implement optimised KC if allocated to the intervention group. 1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \>67% of the minimum expected target duration, if allocated to the intervention arm. 1f. Prepared to implement NeoIPC surveillance. 1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate. 2. Infant level 2a. All high-risk infants (born at \<32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth. EXCLUSION CRITERIA 1 Site level 1. a. Participation in other research that could directly influence the study intervention or outcomes. 2. a. Average StSC duration already exceeding 18 hours per day. 3. a. Anticipated major changes in resistant bacterial colonisation pressure during the study 2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease neonatal sepsis prevention target nosocomial infection prevention target

As listed by the trial registrant

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

Infection prevention Infection, bacterial

How to take part

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

  1. The places running it

    14 sites in 4 countries. 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

  • Aglaia Kyriakou Children's Hospital

    RECRUITING

    Athens, Greece

  • Azienda Ospedaliera Universitaria S.Anna di Ferrara

    RECRUITING

    Ferrara, Italy

  • Azienda Ospedaliera Universitaria di Modena

    RECRUITING

    Modena, Italy

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, United Kingdom

  • Children's Hospital of Eastern Switzerland St.Gallen

    COMPLETED

    Sankt Gallen, Switzerland

  • City St George's, University of London

    RECRUITING

    London, United Kingdom

  • Cruces University Hospital

    RECRUITING

    Bilbao, Spain

  • Hippokration Hospital - Thessaloniki

    COMPLETED

    Thessaloniki, Greece

  • Hospital General Universitario Alicante

    RECRUITING

    Alicante, Spain

  • Hospital Regional Universitario de Málaga (Carlos Haya)

    RECRUITING

    Málaga, Spain

  • Hôpitaux Universitaires de Genève

    COMPLETED

    Geneva, Switzerland

  • Inselspital - University Hospital of Bern

    COMPLETED

    Bern, Switzerland

  • Ioannina University Hospital

    COMPLETED

    Ioannina, Greece

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    RECRUITING

    Norwich, United Kingdom

  • Ospedale San Bortolo di Vicenza

    RECRUITING

    Vicenza, Italy

  • Ospedale Universitario Policlinico Paolo Giaccone

    RECRUITING

    Palermo, Italy

  • Papageorgiou Hospital

    COMPLETED

    Thessaloniki, Greece

  • St Mary's Hospital

    RECRUITING

    Manchester, United Kingdom

  • University General Hospital Attikon

    COMPLETED

    Attiki, Greece

  • University General Hospital of Patras

    RECRUITING

    Pátrai, Greece

  • University Hospital of Heraklion

    COMPLETED

    Heraklion, Greece

  • University Hospitals Coventry and Warwickshire

    RECRUITING

    Coventry, United Kingdom

  • University of Basel Children's Hospital

    COMPLETED

    Basel, Switzerland

  • Universitätsspital Zürich - University Hospital Zurich

    COMPLETED

    Zurich, Switzerland

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