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RECRUITING
NCT05993442
NA

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

Sponsor: PENTA Foundation

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

Any - 32 Weeks

Study Type

INTERVENTIONAL

Enrollment

3080

Start Date

2024-05-28

Completion Date

2026-05

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

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.,

Locations (24)

Aglaia Kyriakou Children's Hospital

Athens, Greece

University General Hospital Attikon

Attiki, Greece

University Hospital of Heraklion

Heraklion, Greece

Ioannina University Hospital

Ioannina, Greece

University General Hospital of Patras

Pátrai, Greece

Hippokration Hospital - Thessaloniki

Thessaloniki, Greece

Papageorgiou Hospital

Thessaloniki, Greece

Azienda Ospedaliera Universitaria S.Anna di Ferrara

Ferrara, Italy

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

Ospedale Universitario Policlinico Paolo Giaccone

Palermo, Italy

Ospedale San Bortolo di Vicenza

Vicenza, Italy

Hospital General Universitario Alicante

Alicante, Spain

Cruces University Hospital

Bilbao, Spain

Hospital Regional Universitario de Málaga (Carlos Haya)

Málaga, Spain

University of Basel Children's Hospital

Basel, Switzerland

Inselspital - University Hospital of Bern

Bern, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Children's Hospital of Eastern Switzerland St.Gallen

Sankt Gallen, Switzerland

Universitätsspital Zürich - University Hospital Zurich

Zurich, Switzerland

Birmingham Heartlands Hospital

Birmingham, United Kingdom

University Hospitals Coventry and Warwickshire

Coventry, United Kingdom

City St George's, University of London

London, United Kingdom

St Mary's Hospital

Manchester, United Kingdom

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, United Kingdom