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
Parallel
Optimised kangaroo care
BehavioralThe 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.,
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.
Resistant bacterial colonisation defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS
Resistant bacterial colonisation is defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS. It will be assessed in high-risk infants through targeted resistome analysis (detection of resistance genes) using PCR-based genomics on stool samples collected during regular PPS. A subset of samples will undergo additional testing, including quantitative cultures, whole genome sequencing, and untargeted shotgun metagenomic sequencing. An infant is considered colonised if PCR identifies genes from at least one of the following highly prevalent resistance gene families in a stool sample: CTX-M (extended-spectrum beta-lactamase), VIM, NDM, KPC, IMP, or OXA-48 (carbapenemase), and vanA or vanB (vancomycin resistance)
Surveillance-based neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data.
Cumulative incidence of neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data. The numerator is the number of high-risk infants with at least one episode of neonatal severe infection/sepsis registered in NeoIPC Surveillance during a study period. The denominator is the total number of high-risk infants registered in NeoIPC Surveillance during the same period.
Infection outcomes assessed with separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis
Will be assessed the separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis (NEC): * Clinical sepsis * LC-BSI * Pneumonia * NEC
Infection outcomes defined with incidence rate number
Will be also define incidence rates of: * Neonatal severe infection/sepsis * LC-BSI * Clinical sepsis Incidence rate is the number of infection episodes divided by the total time the infant contributed to a study period, expressed in infant days. Multiple episodes per infant can be included.
Health economic analysis assessed with cost-effectiveness of optimised KC and implementation approach.
To assess cost-effectiveness of optimised KC and the implementation approach.
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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
