Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
NCT ID: NCT05993442
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3080 participants
INTERVENTIONAL
2024-05-28
2026-03-31
Brief Summary
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Detailed Description
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Sites will be grouped into two staggered phases (with at least 10 sites in each). Within each stagger, sites will be randomized to either the intervention arm or the control arm (standard care). Randomisation will occur at the end of the baseline period, which will be identical for all sites. Intervention sites will then undergo a 2-month wash-in phase during which they will receive training and workshops on implementation strategies for optimized Kangaroo Care (KC). Each neonatal unit/site constitutes a cluster, and the intervention is applied at the unit level.
Following the wash-in phase, the intervention period for intervention sites will last 10 months. During this time, optimised KC-defined as early, repeated, and sustained skin-to-skin contact-will be continuously implemented.
All sites, regardless of their allocation (intervention or control arm), will conduct a baseline data collection phase involving clinical surveillance and colonisation assessments. This includes data and sample collection for all consented high-risk babies present in the unit on the day of assessment. Specifically, all sites will collect stool samples weekly during the baseline period and monthly during the wash-in and intervention periods from all high-risk babies present in the unit on the day of the assessment.
Additionally, one representative site per country from the intervention arm will be selected for further in-depth engagement and data collection by the implementation team. This will gather additional information on intervention fidelity and implementation strategies, including acceptability, appropriateness, feasibility, and sustainability.
At the end of the intervention period, all control sites will be supported and trained to implement the optimised KC using the selected implementation strategies.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Optimised kangaroo care
The sites randomised in this group will adapt the study intervention consisting of:
Component 1: Skin-to-skin contact for optimised KC, describes the targeted level of early, repeated and sustained skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care.
Component 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.
Optimised kangaroo care
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.,
Standard of Care
The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections/sepsis and infection prevention and control measures based on current routine local practice. Standard care in all participating NICUs already includes KC but without specific activities to ensure this is implemented according to international best practice recommendations.
No interventions assigned to this group
Interventions
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Optimised kangaroo care
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.,
Eligibility Criteria
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Inclusion Criteria
* Minimum number of 12 beds offering highest level of neonatal intensive care.
* Availability of or access to -70 to -80°C freezer for storage of research samples.
* Willing to implement optimised KC if allocated to the intervention group.
* Willing to commit to offering the minimum expected target duration or an increase of 50% if NICU is already offering the minimum expected target duration, if allocated to the intervention arm.
* Prepared to implement NeoIPC surveillance
* Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
Exclusion Criteria
* NICU already practices 'long-term' StSC of \> 18 hours. Major expected changes in resistant bacterial colonisation pressure during the study period, for example due to planned move to a new ward.
* Participation in other interventional IPC research projects which might directly influence the study intervention or outcome.
36 Weeks
ALL
No
Sponsors
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St George's, University of London
OTHER
European Clinical Research Alliance for Infectious Diseases (ECRAID)
OTHER
University of Zurich
OTHER
Universiteit Antwerpen
OTHER
Charite University, Berlin, Germany
OTHER
UMC Utrecht
OTHER
Swiss Tropical & Public Health Institute
OTHER
PENTA Foundation
NETWORK
Responsible Party
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Principal Investigators
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Julia Bielicki, PhD
Role: STUDY_CHAIR
St George's, University of London
Locations
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University General Hospital Attikon
Attiki, , Greece
University Hospital of Heraklion
Heraklion, , Greece
Ioannina University Hospital
Ioannina, , Greece
Hippokration Hospital - Thessaloniki
Thessaloniki, , Greece
Papageorgiou Hospital
Thessaloniki, , Greece
University of Basel Children's Hospital
Basel, , Switzerland
Inselspital - University Hospital of Bern
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Children's Hospital of Eastern Switzerland St.Gallen
Sankt Gallen, , Switzerland
Universitätsspital Zürich - University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Vana Papaevangelou, MD
Role: primary
Eleftheria Hatzidaki, MD
Role: primary
Vasileios Giapros, MD
Role: primary
Kosmas Sarafidis, MD
Role: primary
Georgios Mitsiakos, MD
Role: primary
Kerstin Jost, MD
Role: primary
Benedikt Bubl, MD
Role: primary
Flavia Rosa Mangeret, MD
Role: primary
Stefanie Grabner, MD
Role: primary
Susanne Böttger, MD
Role: primary
Related Links
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NeoDeco study is part of the NeoIPC project funded by the European Commission.
Other Identifiers
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NeoDeco
Identifier Type: -
Identifier Source: org_study_id