Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
Recruiting
N/A
Interventional Study
Infection, Bacterial
Infection Prevention
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 32 Weeks
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 3,080 (estimated)
- Sponsor
- PENTA Foundation · Research network
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About This Trial
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 st…
Trial Locations
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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 t…
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