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

March 20, 2026 updated by: PENTA Foundation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3080

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece
      • Attiki, Greece
        • Completed
        • University General Hospital Attikon
      • Heraklion, Greece
        • Completed
        • University Hospital of Heraklion
      • Ioannina, Greece
        • Completed
        • Ioannina University Hospital
      • Pátrai, Greece
        • Recruiting
        • University General Hospital of Patras
        • Contact:
      • Thessaloniki, Greece
        • Completed
        • Hippokration Hospital - Thessaloniki
      • Thessaloniki, Greece
        • Completed
        • Papageorgiou Hospital
  • Italy
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria S.Anna di Ferrara
        • Contact:
      • Modena, Italy
      • Palermo, Italy
        • Recruiting
        • Ospedale Universitario Policlinico Paolo Giaccone
        • Contact:
      • Vicenza, Italy
  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario Alicante
        • Contact:
      • Bilbao, Spain
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga (Carlos Haya)
        • Contact:
  • Switzerland
      • Basel, Switzerland
        • Completed
        • University of Basel Children's Hospital
      • Bern, Switzerland
        • Completed
        • Inselspital - University Hospital of Bern
      • Geneva, Switzerland
        • Completed
        • Hôpitaux Universitaires de Genève
      • Sankt Gallen, Switzerland
        • Completed
        • Children's Hospital of Eastern Switzerland St.Gallen
      • Zurich, Switzerland
        • Completed
        • Universitätsspital Zürich - University Hospital Zurich
  • United Kingdom
      • Birmingham, United Kingdom
      • Coventry, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
        • Recruiting
        • Norfolk and Norwich University Hospital NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optimised kangaroo care

The 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.
Behavioral: Optimised kangaroo care
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.,
No Intervention: Standard of Care
The 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal severe infection/sepsis defined as an episode of one of three infectious entities as registered in the surveillance system
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistant bacterial colonisation defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS
Time Frame: 12 months
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)
12 months
Surveillance-based neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data.
Time Frame: 12 months
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.
12 months
Infection outcomes assessed with separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis
Time Frame: 12 Months

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
12 Months
Infection outcomes defined with incidence rate number
Time Frame: 12 Months

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.
12 Months
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
Time Frame: 12 months
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.
12 months
Neonatal unit length of stay: total number of calendar days an infant was hospitalised on the neonatal unit during the study period
Time Frame: 12 months
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.
12 months
Antibiotic treatment recording through both NeoIPC Surveillance and clinical data collection in PPS
Time Frame: 12 months

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.
12 months
StSC duration in hours and minutes in the preceding 24 hours
Time Frame: 12 months
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.
12 months
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
Time Frame: 12 months

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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health economic analysis assessed with cost-effectiveness of optimised KC and implementation approach.
Time Frame: 12 months
To assess cost-effectiveness of optimised KC and the implementation approach.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PENTA Foundation

Collaborators

Charite University, Berlin, Germany
University of Zurich
UMC Utrecht
Swiss Tropical & Public Health Institute
Universiteit Antwerpen
St George's, University of London
European Clinical Research Alliance for Infectious Diseases (ECRAID)

Investigators

  • Study Chair: Julia Bielicki, PhD, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoDeco

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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