Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.

Last updated: December 23, 2024
Sponsor: PENTA Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bacterial Infections

Treatment

Optimising kangaroo care

Optimised kangaroo care

Clinical Study ID

NCT05993442
NeoDeco
  • Ages < 36
  • All Genders

Study Summary

NeoDeco is a pragmatic, multicenter, parallel group, cluster randomised hybrid effectiveness-implementation study with baseline assessment, wash-in period and staggered randomisation. All sites will be offered the implementation support for optimised Kangaroo Care (KC) as part of the study; however, intervention sites will be randomised to immediate receipt of implementation support whereas standard care sites will be offered this after the study period.

Eligibility Criteria

Inclusion

In NeoDeco there are no participant inclusion or exclusion criteria because this is a cluster randomised trial, so the intervention will be applied to all babies admitted to the neonatal intensive care unit as a cluster.

However, the neonatal intensive care units will have to meet the following criteria to be involved in the study:

Inclusion Criteria:

  • European NICUs that provide routine care of extremely premature infants (< 28 weeks'gestational age).

  • 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 allocatedto the intervention arm.

  • Prepared to implement NeoIPC surveillance

  • Adequate resources and expertise and approvals from relevant Research EthicsCommittees, as appropriate.

Exclusion

Exclusion Criteria:

  • NICU already practices 'long-term' StSC of > 18 hours. Major expected changes inresistant bacterial colonisation pressure during the study period, for example dueto planned move to a new ward.

  • Participation in other interventional IPC research projects which might directlyinfluence the study intervention or outcome.

Study Design

Total Participants: 3080
Treatment Group(s): 2
Primary Treatment: Optimising kangaroo care
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
March 31, 2026

Study Description

The NeoDECO trial is a cluster-randomized trial involving up to 24 neonatal units across 5 European countries: Switzerland, Italy, Greece, Spain, and the United Kingdom.

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.

Connect with a study center

  • University General Hospital Attikon

    Attikí,
    Greece

    Active - Recruiting

  • University Hospital of Heraklion

    Heraklion,
    Greece

    Active - Recruiting

  • Ioannina University Hospital

    Ioánnina,
    Greece

    Active - Recruiting

  • Hippokration Hospital - Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • Papageorgiou Hospital

    Thessaloníki,
    Greece

    Active - Recruiting

  • University of Basel Children's Hospital

    Basel,
    Switzerland

    Active - Recruiting

  • Inselspital - University Hospital of Bern

    Bern,
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires de Genève

    Geneva,
    Switzerland

    Active - Recruiting

  • Children's Hospital of Eastern Switzerland St.Gallen

    Saint-Gall,
    Switzerland

    Active - Recruiting

  • Universitätsspital Zürich - University Hospital Zurich

    Zürich,
    Switzerland

    Active - Recruiting

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