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: Recruiting
Location: See all (24) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:
⁃ 1\. Site level
⁃ 1a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation).
⁃ 1b. Minimum capacity of 12 beds.
⁃ 1c. Access to a -70 to -80°C freezer for storage of research samples
⁃ 1d. Willing to implement optimised KC if allocated to the intervention group.
⁃ 1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \>67% of the minimum expected target duration, if allocated to the intervention arm.
⁃ 1f. Prepared to implement NeoIPC surveillance.
• g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
• Infant level
⁃ 2a. All high-risk infants (born at \<32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth.
Locations
Other Locations
Greece
Aglaia Kyriakou Children's Hospital
RECRUITING
Athens
University General Hospital Attikon
COMPLETED
Attiki
University Hospital of Heraklion
COMPLETED
Heraklion
Ioannina University Hospital
COMPLETED
Ioannina
University General Hospital of Patras
RECRUITING
Pátrai
Hippokration Hospital - Thessaloniki
COMPLETED
Thessaloniki
Papageorgiou Hospital
COMPLETED
Thessaloniki
Italy
Azienda Ospedaliera Universitaria S.Anna di Ferrara
RECRUITING
Ferrara
Azienda Ospedaliera Universitaria di Modena
RECRUITING
Modena
Ospedale Universitario Policlinico Paolo Giaccone
RECRUITING
Palermo
Ospedale San Bortolo di Vicenza
RECRUITING
Vicenza
Spain
Hospital General Universitario Alicante
RECRUITING
Alicante
Cruces University Hospital
RECRUITING
Bilbao
Hospital Regional Universitario de Málaga (Carlos Haya)
RECRUITING
Málaga
Switzerland
University of Basel Children's Hospital
COMPLETED
Basel
Inselspital - University Hospital of Bern
COMPLETED
Bern
Hôpitaux Universitaires de Genève
COMPLETED
Geneva
Children's Hospital of Eastern Switzerland St.Gallen
COMPLETED
Sankt Gallen
Universitätsspital Zürich - University Hospital Zurich
COMPLETED
Zurich
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
University Hospitals Coventry and Warwickshire
RECRUITING
Coventry
City St George's, University of London
RECRUITING
London
St Mary's Hospital
RECRUITING
Manchester
Norfolk and Norwich University Hospital NHS Foundation Trust
RECRUITING
Norwich
Contact Information
Primary
Selene Parenti
selene.parenti@pentafoundation.org
+39 378 309 4518
Time Frame
Start Date:2024-05-28
Estimated Completion Date:2026-05
Participants
Target number of participants:3080
Treatments
Experimental: Optimised kangaroo care
The sites randomised in this group will adapt the study intervention consisting of:~Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of early, repeated and sustained skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care.~Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.
No_intervention: Standard of Care
The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice. Standard care in all participating NICUs already includes KC but without specific activities to ensure this is implemented according to international best practice recommendations.
Collaborators: UMC Utrecht, European Clinical Research Alliance for Infectious Diseases (ECRAID), St George's, University of London, Charite University, Berlin, Germany, Universiteit Antwerpen, Swiss Tropical & Public Health Institute, University of Zurich