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.
g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
Infant level
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
PENTA Foundation
Lead sponsor
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
St George's, University of London
Collaborator