Improving Kangaroo Care to Prevent Infections in High-risk Infants in NICUs
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.
This study is testing whether improved Kangaroo Care can help prevent infections in high-risk infants in neonatal intensive care units.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3080 (estimated) |
| Ages | N/A to 32 Weeks |
| Sex | All |
| Sponsor | PENTA Foundation Research network |
| Locations | 24 sites (Athens and 23 other locations) |
| Trial ID | NCT05993442 on ClinicalTrials.gov |
What this trial studies
The NeoDeco trial is a multicenter, cluster-randomized study conducted across 24 neonatal units in five European countries. It aims to implement optimized Kangaroo Care (KC) to reduce severe infections and resistant bacterial colonization among high-risk infants in neonatal intensive care units (NICUs). The study involves a baseline assessment, a wash-in period for training, and a 10-month intervention period where KC will be continuously applied. Data on clinical outcomes and bacterial colonization will be collected from all eligible infants during the study.
Who should consider this trial
Good fit: Ideal candidates for this study are high-risk infants admitted to neonatal intensive care units, particularly those born extremely premature.
Not a fit: Patients who are not admitted to participating NICUs or those who do not meet the criteria for high-risk infants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of severe infections and improve health outcomes for high-risk infants in NICUs.
How similar studies have performed: Previous studies have shown promising results with similar approaches to Kangaroo Care, indicating potential for success in this novel implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Athens and 23 other locations
- 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)
Study contacts
- Study coordinator: Selene Parenti
- Email: selene.parenti@pentafoundation.org
- Phone: +39 378 309 4518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.