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.
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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…
Contacts

Selene Parenti

+39 378 309 4518

selene.parenti@pentafoundation.org

CONTACT