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

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

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.,

Sponsors & Collaborators

• European Clinical Research Alliance for Infectious Diseases (ECRAID)

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• St George's, University of London

  collaborator OTHER

• PENTA Foundation

  lead NETWORK

Principal Investigators

• Julia Bielicki, PhD · St George's, University of London

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-28

Primary Completion

2026-04-30

Completion

2026-05-31

Countries

• Greece
• Italy
• Spain
• Switzerland
• United Kingdom

Study Locations