Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
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.
PENTA Foundation
3,080 participants
May 28, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- \. Site level
- a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation).
- b. Minimum capacity of 12 beds.
- c. Access to a -70 to -80°C freezer for storage of research samples
- d. Willing to implement optimised KC if allocated to the intervention group.
- e. 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.
- f. Prepared to implement NeoIPC surveillance.
- g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
- Infant level
- a. 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 Criteria3
- a. Participation in other research that could directly influence the study intervention or outcomes.
- a. Average StSC duration already exceeding 18 hours per day.
- a. Anticipated major changes in resistant bacterial colonisation pressure during the study
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Interventions
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.,
Locations(24)
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NCT05993442