Actively Recruiting
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Led by PENTA Foundation · Updated on 2026-03-25
3080
Participants Needed
24
Research Sites
100 weeks
Total Duration
On this page
Sponsors
P
PENTA Foundation
Lead Sponsor
E
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonatal units that routinely care for extremely premature infants born before 28 weeks' gestation
- Neonatal units with a minimum capacity of 12 beds
- Neonatal units with access to -70 to -80°C freezers for storing research samples
- Neonatal units willing to implement optimised Kangaroo Care if assigned to the intervention group
- Units willing to offer the minimum target duration of Kangaroo Care or increase it by 50% if already exceeding 67% of the target
- Units prepared to implement NeoIPC surveillance
- Units with adequate resources, expertise, and necessary ethical approvals
- High-risk infants born before 32 weeks' gestation admitted to participating units, regardless of care complexity or room type
You will not qualify if you...
- Neonatal units involved in other research that could affect this study's intervention or outcomes
- Units where average skin-to-skin contact duration already exceeds 18 hours per day
- Units anticipating major changes in resistant bacterial colonisation pressure during the study
- Infants whose parents or guardians do not provide written informed consent for data and sample collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Aglaia Kyriakou Children's Hospital
Athens, Greece
Actively Recruiting
2
University General Hospital Attikon
Attiki, Greece
Completed
3
University Hospital of Heraklion
Heraklion, Greece
Completed
4
Ioannina University Hospital
Ioannina, Greece
Completed
5
University General Hospital of Patras
Pátrai, Greece
Actively Recruiting
6
Hippokration Hospital - Thessaloniki
Thessaloniki, Greece
Completed
7
Papageorgiou Hospital
Thessaloniki, Greece
Completed
8
Azienda Ospedaliera Universitaria S.Anna di Ferrara
Ferrara, Italy
Actively Recruiting
9
Azienda Ospedaliera Universitaria di Modena
Modena, Italy
Actively Recruiting
10
Ospedale Universitario Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
11
Ospedale San Bortolo di Vicenza
Vicenza, Italy
Actively Recruiting
12
Hospital General Universitario Alicante
Alicante, Spain
Actively Recruiting
13
Cruces University Hospital
Bilbao, Spain
Actively Recruiting
14
Hospital Regional Universitario de Málaga (Carlos Haya)
Málaga, Spain
Actively Recruiting
15
University of Basel Children's Hospital
Basel, Switzerland
Completed
16
Inselspital - University Hospital of Bern
Bern, Switzerland
Completed
17
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Completed
18
Children's Hospital of Eastern Switzerland St.Gallen
Sankt Gallen, Switzerland
Completed
19
Universitätsspital Zürich - University Hospital Zurich
Zurich, Switzerland
Completed
20
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Actively Recruiting
21
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Actively Recruiting
22
City St George's, University of London
London, United Kingdom
Actively Recruiting
23
St Mary's Hospital
Manchester, United Kingdom
Actively Recruiting
24
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
Actively Recruiting
Research Team
S
Selene Parenti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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