AzTrials
AzTrials

Infection, BacterialNeoDecoNCT05993442

Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.

A study testing Optimised kangaroo care in people with Infection, Bacterial and Infection Prevention, run by PENTA Foundation at 24 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. Read more about this study

Who is it for?
Ages Up to 32 weeks
Conditions the study is for
Infection, Bacterial, Infection Prevention
What is being tested?
Optimised kangaroo care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,080 participants
Where
24 sitesin 5 countries
Study dates
28 May 2024to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 10Show fewer
  • 1f. Prepared to implement NeoIPC surveillance.
  • g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
  • 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.

Who cannot join

  • a. Participation in other research that could directly influence the study intervention or outcomes.
  • a. Average StSC duration already exceeding 18 hours per day.
  • 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.

Trial locations and contacts

24 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Selene Parenti contact

+39 378 309 4518

selene.parenti@pentafoundation.org

24 sites in 5 countries

Greece7 sites, 2 recruiting

  • Aglaia Kyriakou Children's Hospital

    Athens

    Maria Tsolia, MD, maria.n.tsolia@gmail.com

    Recruiting

  • University General Hospital Attikon

    Attiki

    Completed

  • University Hospital of Heraklion

    Heraklion

    Completed

  • Ioannina University Hospital

    Ioannina

    Completed

  • University General Hospital of Patras

    Pátrai

    Gabriel Dimitriou, MD, gdim@upatras.gr

    Recruiting

  • Hippokration Hospital - Thessaloniki

    Thessaloniki

    Completed

  • Papageorgiou Hospital

    Thessaloniki

    Completed

Other trials in Greece

Switzerland5 sites

  • University of Basel Children's Hospital

    Basel

    Completed

  • Inselspital - University Hospital of Bern

    Bern

    Completed

  • Hôpitaux Universitaires de Genève

    Geneva

    Completed

  • Children's Hospital of Eastern Switzerland St.Gallen

    Sankt Gallen

    Completed

  • Universitätsspital Zürich - University Hospital Zurich

    Zurich

    Completed

Other trials in Switzerland

United Kingdom5 sites, 5 recruiting

  • Birmingham Heartlands Hospital

    Birmingham

    Imogen Storey, MD, imogen.storey@uhb.nhs.uk

    Recruiting

  • University Hospitals Coventry and Warwickshire

    Coventry

    Sarah Williamson, MD, sarah.williamson2@uhcw.nhs.uk

    Recruiting

  • City St George's, University of London

    London

    Amy Reid, MD, amy.reid@stgeorges.nhs.uk

    Recruiting

  • St Mary's Hospital

    Manchester

    Susan Dowd, MD, susan.dowd@mft.nhs.uk

    Recruiting

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich

    Paul Clarke, MD, paul.clarke@nnuh.nhs.uk

    Recruiting

Other trials in United Kingdom

Italy4 sites, 4 recruiting

  • Azienda Ospedaliera Universitaria S.Anna di Ferrara

    Ferrara

    Silvia Fanaro, MD, fnrslv@unife.it

    Recruiting

  • Azienda Ospedaliera Universitaria di Modena

    Modena

    Alberto Berardi, MD, alberto.berardi@unimore.it

    Recruiting

  • Ospedale Universitario Policlinico Paolo Giaccone

    Palermo

    Mario Giuffrè, MD, mario.giuffre@unipa.it

    Recruiting

  • Ospedale San Bortolo di Vicenza

    Vicenza

    Stefania Vedovato, MD, stefania.vedovato@aulss8.veneto.it

    Recruiting

Other trials in Italy

Spain3 sites, 3 recruiting

  • Hospital General Universitario Alicante

    Alicante

    Caridad Tapia Collados, MD, catapiac@gmail.com

    Recruiting

  • Cruces University Hospital

    Bilbao

    Begoña Loureiro Gonzalez, MD, begona.loureirogonzalez@osakidetza.eus

    Recruiting

  • Hospital Regional Universitario de Málaga (Carlos Haya)

    Málaga

    María C López Castillo, MD, mcarmen.lopez123@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation-effectiveness Study.

NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. The trial includes a baseline period, a wash-in phase, and a staggered randomisation approach. The primary focus of the NeoDeco study is on high-risk preterm infants born at less than 32 weeks' gestational age, a population particularly vulnerable to hospital-acquired infections and sepsis during their initial hospital stay. By investigating hospital-acquired infections specifically, the study targets the period during which optimised KC practices are likely to have the most significant impact.

Read the detailed description

NeoDECO trial is a cluster-randomised study involving up to 24 neonatal units (clusters) across five European countries: Switzerland, Italy, Greece, Spain, and the United Kingdom. Each participating neonatal unit constitutes a cluster, with the intervention implemented at the unit level. The study is structured into two staggered. Within each stagger, sites are randomised 1:1 to either the intervention arm or control arm (standard care).

Control Arm (Standard Care): Sites randomised to the control arm will continue with current routine practices, which might include kangaroo care (KC), skin-to-skin contact (StSC), infection prevention and control measures, and the treatment of severe infections or neonatal sepsis. While KC is already part of routine care in all participating units, there are no structured efforts in place to ensure adherence to international best practice guidelines.

Intervention Arm (Optimised KC): Sites in the intervention arm will implement optimised KC in line with internationally recognised best practice recommendations. The intervention is comprised of two key components:

Component 1: Skin-to-Skin Contact (StSC) for Optimised KC This component defines the desired frequency, duration, and initiation timing of early, repeated, and sustained StSC that characterise optimised KC in high-technology neonatal environments where KC is already offered.

Component 2: Implementation Support This component focuses on engaging clinical staff responsible for KC delivery. Implementation support includes training, ongoing support, and tools to embed optimised KC into routine practice. The goal is to facilitate sustained practice change through staff empowerment and structured implementation strategies.

Following randomisation, sites allocated to the intervention arm will undergo an intervention period of up to 10 months. All sites-regardless of allocation-will collect clinical data and biological samples from all consented high-risk infants present in the unit on the day of the assessment. The collected samples will be analyzied centrally and help monitor colonisation and infection patterns over time, with particular focus on the incidence of hospital-acquired infections.

To evaluate the fidelity and quality of the intervention delivery, one representative intervention site from each participating country will be selected for enhanced data collection and engagement with the implementation team. These sites will participate in more detailed assessments related to: fidelity of intervention delivery, implementation strategies used, acceptability, appropriateness, and feasibility of optimised KC.

At the conclusion of the study, all control sites will receive full support and training to implement optimised KC using the tested implementation strategies. This ensures equitable access to the intervention benefits across all participating units and supports the potential scale-up of optimised KC practices beyond the trial period.

Being tested
Optimised kangaroo care
Keywords
Nosocomial Infection, Prevention, Cluster, Implementation science, Surveillance, Kangaroo Care, Skin to Skin Contact, Neonatal Intensive Care Unit, NICU, Neonatal severe infection, Resistant bacterial, Pre-term infants
Medical subject headings
Bacterial Infections, Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimised kangaroo careBehavioural

    The intervention of optimised KC implementation consists of two components. Component 1 defines the targeted StSC for optimised KC, while component 2 is the implementation support to put in place a tailored implementation strategy.,

Study groups in NCT05993442
Study groupRoleWhat they receive
Optimised kangaroo careExperimentalThe sites randomised in this group will adapt the study intervention consisting of: Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of early, repeated and sustained skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care. Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.
Receives: Behavioral: Optimised kangaroo care
Standard of CareNo interventionThe sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice. Standard care in all participating NICUs already includes KC but without specific activities to ensure this is implemented according to international best practice recommendations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal severe infection/sepsis defined as an episode of one of three infectious entities as registered in the surveillance system

    The clinical primary endpoint neonatal severe infection/sepsis will be assessed through NeoIPC surveillance. Neonatal severe infection/sepsis is defined as an episode of one of three infectious entities as registered in the surveillance system: clinical sepsis, a laboratory-confirmed bloodstream infection or pneumonia, where the first symptoms occur on day 3 after admission or later (admission day is day 1) in high-risk infants. For infants admitted directly after birth episodes first symptoms of infection occur after 72 hours of life.

    Measured: 12 months

Secondary outcomes (9)

  1. Resistant bacterial colonisation defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS

    Resistant bacterial colonisation is defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS. It will be assessed in high-risk infants through targeted resistome analysis (detection of resistance genes) using PCR-based genomics on stool samples collected during regular PPS. A subset of samples will undergo additional testing, including quantitative cultures, whole genome sequencing, and untargeted shotgun metagenomic sequencing. An infant is considered colonised if PCR identifies genes from at least one of the following highly prevalent resistance gene families in a stool sample: CTX-M (extended-spectrum beta-lactamase), VIM, NDM, KPC, IMP, or OXA-48 (carbapenemase), and vanA or vanB (vancomycin resistance)

    Measured: 12 months

  2. Surveillance-based neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data.

    Cumulative incidence of neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data. The numerator is the number of high-risk infants with at least one episode of neonatal severe infection/sepsis registered in NeoIPC Surveillance during a study period. The denominator is the total number of high-risk infants registered in NeoIPC Surveillance during the same period.

    Measured: 12 months

  3. Infection outcomes assessed with separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis

    Will be assessed the separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis (NEC):

    • Clinical sepsis
    • LC-BSI
    • Pneumonia
    • NEC

    Measured: 12 Months

  4. Infection outcomes defined with incidence rate number

    Will be also define incidence rates of:

    • Neonatal severe infection/sepsis
    • LC-BSI
    • Clinical sepsis Incidence rate is the number of infection episodes divided by the total time the infant contributed to a study period, expressed in infant days. Multiple episodes per infant can be included.

    Measured: 12 Months

  5. Major non-infection neonatal morbidity collected aggregated at the cluster level, separately for the baseline and intervention period, and is therefore a unit-level endpoint

    Major non-infection neonatal morbidity includes type 1 retinopathy of prematurity (ROP), high-grade intraventricular haemorrhage (IVH), cystic periventricular leukomalacia (PVL) and/or bronchopulmonary dysplasia (BPD) at 36 weeks' post-menstrual age, as collected in the unit-level data collection. Cumulative incidence of major non-infection neonatal morbidity is the number of high-risk infants with a first diagnosis of any of the major morbidity items divided by the total number of high-risk infants admitted at a site during a study period. It is collected aggregated at the cluster level, separately for the baseline and intervention period, and is therefore a unit-level endpoint.

    Measured: 12 months

  6. Neonatal unit length of stay: total number of calendar days an infant was hospitalised on the neonatal unit during the study period

    Neonatal unit length of stay is the total number of calendar days an infant was hospitalised on the neonatal unit during the study period, independent of whether these are accrued as part of a primary or re-admission.

    Measured: 12 months

  7. Antibiotic treatment recording through both NeoIPC Surveillance and clinical data collection in PPS

    Sites will record antibiotic receipt during admission until discharge in infants with informed consent in place through both NeoIPC Surveillance and clinical data collection in PPS.

    Days on antibiotic treatment is the total number of calendar days an infant received one or more antibiotics divided by the total days the infant contributed to a study period, expressed in infant days.

    Measured: 12 months

  8. StSC duration in hours and minutes in the preceding 24 hours

    Sites will record StSC duration in hours and minutes in the preceding 24 hours in all infants with informed consent in place and hospitalized at the day of a weekly PPS.

    Measured: 12 months

  9. StSC target attainment: the minimum expected target duration of StSC is a site-specific total daily duration of StSC to be provided per infant per day

    The minimum expected target duration of StSC is a site-specific total daily duration of StSC to be provided per infant per day.

    The proportion of infants receiving the minimum expected target duration of StSC is the number of infants contributing to a site's PPS that received the local minimum expected target duration of StSC divided by the total number of infants contributing to the same PPS.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start28 May 2024
  3. Primary completionApr 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study intervention has two components: Component 1 describes the targeted level of early, repeated and sustained StSC considered to represent optimised KC in a high-technology neonatal unit environment. Component 2 is the implementation support to put in place a tailored strategy for the implementation of StSC as part of optimised KC. It directly targets clinical staff in the neonatal unit who may be involved in offering StSC as part of KC.
Masking
None (open label)
Enrolment
3,080 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993442
Sponsor's protocol ID
NeoDeco
Acronym
NeoDeco
Status last verified
Feb 2026
First submitted
28 Jun 2023
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schultes MT, Baenziger J, Nyantakyi E, Wu CX, Ferrari G, Sieswerda E, van Werkhoven CH, Minotti C, Wolfensberger A, Tediosi F, D'Ambrosio F, Bielicki JA, Clack L; NeoIPC Consortium. Implementation of optimized kangaroo care for infection prevention and control in neonatal intensive care units (NeoIPC): Protocol for the implementation elements of a multicenter parallel cluster randomized hybrid type 2 implementation-effectiveness study. Implement Sci. 2026 Feb 27;21(1):26. doi: 10.1186/s13012-026-01488-1.

    PubMed 41749274

Questions about this trial

What is this clinical trial studying?

A study testing Optimised kangaroo care in people with Infection, Bacterial and Infection Prevention, run by PENTA Foundation at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Greece, Switzerland, United Kingdom, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Selene Parenti (+39 378 309 4518, selene.parenti@pentafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal severe infection/sepsis defined as an episode of one of three infectious entities as registered in the surveillance system (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in