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Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Sponsor: PENTA Foundation
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
Conditions
Interventions
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