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

Recruiting now · Not applicable

Conditions studied: Infection, Bacterial, Infection Prevention

In brief

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.

Key facts

Study ID

NCT05993442

Run by

PENTA Foundation

People needed

3080

Starts

2024-05-28

Expected to finish

2026-05-01

Last updated by the study team

2026-03-25

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• EXCLUSION CRITERIA 1 Site 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
• 2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.

Where it is running

• Norfolk and Norwich University Hospital NHS Foundation Trust — Norwich, United Kingdom (enrolling)
• Ospedale Universitario Policlinico Paolo Giaccone — Palermo, Italy (enrolling)
• Ospedale San Bortolo di Vicenza — Vicenza, Italy (enrolling)
• Hospital General Universitario Alicante — Alicante, Spain (enrolling)
• Cruces University Hospital — Bilbao, Spain (enrolling)
• Hospital Regional Universitario de Málaga (Carlos Haya) — Málaga, Spain (enrolling)
• Birmingham Heartlands Hospital — Birmingham, United Kingdom (enrolling)
• University Hospitals Coventry and Warwickshire — Coventry, United Kingdom (enrolling)
• City St George's, University of London — London, United Kingdom (enrolling)
• St Mary's Hospital — Manchester, United Kingdom (enrolling)
• Aglaia Kyriakou Children's Hospital — Athens, Greece (enrolling)
• University General Hospital of Patras — Pátrai, Greece (enrolling)
• Azienda Ospedaliera Universitaria S.Anna di Ferrara — Ferrara, Italy (enrolling)
• Azienda Ospedaliera Universitaria di Modena — Modena, Italy (enrolling)
• University General Hospital Attikon — Attiki, Greece
• University Hospital of Heraklion — Heraklion, Greece
• Ioannina University Hospital — Ioannina, Greece
• Hôpitaux Universitaires de Genève — Geneva, Switzerland
• Hippokration Hospital - Thessaloniki — Thessaloniki, Greece
• Papageorgiou Hospital — Thessaloniki, Greece
• Children's Hospital of Eastern Switzerland St.Gallen — Sankt Gallen, Switzerland
• Universitätsspital Zürich - University Hospital Zurich — Zurich, Switzerland
• University of Basel Children's Hospital — Basel, Switzerland
• Inselspital - University Hospital of Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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