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Clinical Trials in Spain / NCT05993442
Recruiting Not applicable

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

NCT05993442 · tracked via the Priya Life Science Spain tracker
Sponsor
PENTA Foundation
Phase
Not applicable
Started
2024-05-28
Last updated
2026-03-25

Condition(s) studied

Infection, BacterialInfection Prevention

Investigational drug(s) / intervention(s)

Optimised kangaroo care

Optimised kangaroo care: The 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.,

Study 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

Sex
ALL
Min age
—
Max age
32 Weeks
Healthy volunteers
No
INCLUSION CRITERIA 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. 1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate. 2. 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 1. a. Participation in other research that could directly influence the study intervention or outcomes. 2. a. Average StSC duration already exceeding 18 hours per day. 3. 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.

Primary outcome measure(s)

  • Neonatal severe infection/sepsis defined as an episode of one of three infectious entities as registered in the surveillance system — 12 months
    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.

Trial sites (24)

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

More PENTA Foundation trials in Spain

DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05993442 on ClinicalTrials.gov ↗ ← All trials in Spain