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

Infection, Bacterial Clinical Trial

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.

Status Not yet recruiting

Clinical Trial Summary

NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid effectiveness-implementation study with baseline assessment, wash-in period and staggered randomisation. All sites will be offered the implementation support for optimised Kangaroo Care (KC) as part of the study; however, intervention sites will be randomised to immediate receipt of implementation support whereas standard care sites will be offered this after the study period.

Clinical Trial Description

The NeoDECO trial is a cluster randomised trial of 24 neonatal units in 5 European countries (Switzerland, Italy, Greece, Spain and United Kingdom). Each neonatal unit/site is a cluster and the intervention is applied at the unit-level.

Sites will be grouped into staggers. Within each stagger, sites will be randomised to the intervention or control (standard care) arm. The randomisation will occur at the end of the baseline period which is identical for all sites. Intervention sites will then undergo a 2-month wash-in phase during which time they will receive training and workshops on implementation strategies for optimised KC.

Following the wash-in phase, the intervention period for intervention sites will last 12 months, during which time optimised KC (defined as early, repeated and sustained StSC) will be continuously implemented.

All sites (both intervention and control arm) will carry out a baseline data collection phase of clinical surveillance and colonisation assessments. All sites will also conduct weekly collection of skin swabs and stool samples from all babies in the unit on the day of the assessment.

In addition, one representative site per country of the intervention arm will be selected for further in-depth engagement and data collection with the implementation team to gather further information on intervention fidelity and implementation strategies, including acceptability, appropriateness, feasibility and sustainability.

At the end of the intervention period, all control sites will be supported and trained to implement the optimised KC using the selected implementation strategies. ;

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infections

• NCT number: NCT05993442
• Study type: Interventional
• Source: PENTA Foundation
• Contact: Federica D'Ambrosio
• Phone: +39 378 302 9089
• Email: federica.dambrosio@pentafoundation.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Completion date: September 2026