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New treatment option for Infection, Bacterial
Official title Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
ClinicalTrials.gov ID: NCT05993442
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 32
You may be able to join if
- 1\. Site level 1a. Neonatal unit that provide routinely cares for extremely premature infants (\ 67% of the minimum expected target duration, if...
- g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
- Infant level 2a. All high-risk infants (born at \<32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care...
You likely can't join if
- 1 Site level
- 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 2 Infant level 2a. No infant-level exclusion criteria for...
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece
- Attiki, Greece
- Heraklion, Greece
- Ioannina, Greece
- Pátrai, Greece
- Thessaloniki, Greece
- Ferrara, Italy
- Modena, Italy
- Palermo, Italy
- Vicenza, Italy
- Alicante, Spain
- Bilbao, Spain
- Málaga, Spain
- Basel, Switzerland
- Bern, Switzerland
- Geneva, Switzerland
- Sankt Gallen, Switzerland
- Zurich, Switzerland
- Birmingham, United Kingdom
- Coventry, United Kingdom
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 32 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece; Attiki, Greece; Heraklion, Greece; Ioannina, Greece; Pátrai, Greece; Thessaloniki, Greece and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.