NCT05993442 Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
| NCT ID | NCT05993442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PENTA Foundation |
| Condition | Infection, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,080 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,080 participants in total. It began in 2024-05-28 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Julia Bielicki, PhD
STUDY CHAIR
St George's, University of London
Frequently Asked Questions
Who can join the NCT05993442 clinical trial?
This trial is open to participants of all sexes, up to 32 Weeks, studying Infection, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05993442 currently recruiting?
Yes, NCT05993442 is actively recruiting participants. Contact the research team at selene.parenti@pentafoundation.org for enrollment information.
Where is the NCT05993442 trial being conducted?
This trial is being conducted at Athens, Greece, Attiki, Greece, Heraklion, Greece, Ioannina, Greece and 11 additional locations.
Who is sponsoring the NCT05993442 clinical trial?
NCT05993442 is sponsored by PENTA Foundation. The principal investigator is Julia Bielicki, PhD at St George's, University of London. The trial plans to enroll 3,080 participants.