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

NCT05993442 | Recruiting DMC

• 1 other identifier: NeoDeco
• Study Type: interventional
• Target: 3,080
• Locations: 5 countries
• Sites: 24

Brief 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. 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.

Conditions

Infection, Bacterial; Infection Prevention

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

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (9)

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

  12 months

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

  12 months

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

  12 Months

• Infection outcomes defined with incidence rate number

  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

  12 months

Other Outcomes (1)

• Health economic analysis assessed with cost-effectiveness of optimised KC and implementation approach.

  12 months

Study Arms (2)

Optimised kangaroo care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Optimised kangaroo care BEHAVIORAL

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.,

Optimised kangaroo care

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Site level
• a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation).
• b. Minimum capacity of 12 beds.
• c. Access to a -70 to -80°C freezer for storage of research samples
• d. Willing to implement optimised KC if allocated to the intervention group.
• e. 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.
• f. Prepared to implement NeoIPC surveillance.
• g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
• Infant level
• a. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (24)

Aglaia Kyriakou Children's Hospital

Athens, Greece

RECRUITING

University General Hospital Attikon

Attiki, Greece

COMPLETED

University Hospital of Heraklion

Heraklion, Greece

COMPLETED

Ioannina University Hospital

Ioannina, Greece

COMPLETED

University General Hospital of Patras

Pátrai, Greece

RECRUITING

Hippokration Hospital - Thessaloniki

Thessaloniki, Greece

COMPLETED

Papageorgiou Hospital

Thessaloniki, Greece

COMPLETED

Azienda Ospedaliera Universitaria S.Anna di Ferrara

Ferrara, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

RECRUITING

Ospedale Universitario Policlinico Paolo Giaccone

Palermo, Italy

RECRUITING

Ospedale San Bortolo di Vicenza

Vicenza, Italy

RECRUITING

Hospital General Universitario Alicante

Alicante, Spain

RECRUITING

Cruces University Hospital

Bilbao, Spain

RECRUITING

Hospital Regional Universitario de Málaga (Carlos Haya)

Málaga, Spain

RECRUITING

University of Basel Children's Hospital

Basel, Switzerland

COMPLETED

Inselspital - University Hospital of Bern

Bern, Switzerland

COMPLETED

Hôpitaux Universitaires de Genève

Geneva, Switzerland

COMPLETED

Children's Hospital of Eastern Switzerland St.Gallen

Sankt Gallen, Switzerland

COMPLETED

Universitätsspital Zürich - University Hospital Zurich

Zurich, Switzerland

COMPLETED

Birmingham Heartlands Hospital

Birmingham, United Kingdom

RECRUITING

University Hospitals Coventry and Warwickshire

Coventry, United Kingdom

RECRUITING

City St George's, University of London

London, United Kingdom

RECRUITING

St Mary's Hospital

Manchester, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, United Kingdom

RECRUITING

Related Publications (1)

• 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; and the 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. doi: 10.1186/s13012-026-01488-1. Online ahead of print.

  PMID: 41749274 DERIVED

Related Links

• The NeoDeco study is part of the NeoIPC project, funded by the European Union's Horizon 2020 research and innovation programme under grant agreement no. 965328.

MeSH Terms

Conditions

Bacterial Infections; Cross Infection

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Bielicki, PhD

  St George's, University of London

  STUDY CHAIR

Central Study Contacts

Selene Parenti

CONTACT

+39 378 309 4518; selene.parenti@pentafoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: August 15, 2023
• Study Start: May 28, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5); GR (7); IT (4); ES (3); GB (5)