Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
- Conditions
- Infection, Bacterial
- Interventions
- Behavioral: Optimised kangaroo care
- Registration Number
- NCT05993442
- Lead Sponsor
- PENTA Foundation
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3080
- 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 allocated to the intervention arm.
- Prepared to implement NeoIPC surveillance
- Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group 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.
- Primary Outcome Measures
Name Time Method Neonatal severe infection/sepsis 12 months The cumulative incidence of neonatal severe infection/sepsis in high-risk infants during their NICU stay will be analysed using mixed-effects logistic regression analysis with a random intercept for hospital. The determinant of interest will be the randomly allocated intervention. Co-variates in the analysis include the variables used for restricted randomisation and important individual-level infant characteristics present at admission: birth weight group, gestational age group and mode of delivery (vaginal birth or Caesarean section).
Resistant bacterial colonisation over time 12 months The prevalence of resistant bacterial colonisation over time in high-risk infants admitted to the NICU will be analysed using mixed effects time-series analysis with a random intercept and random time-slope at the hospital level. Individual data will be analysed with a binary outcome (detection or no detection). Data of the pre-trial and full trial period will be visualised, but only PPS collected after the wash-in period (or after the same period in control hospitals) will be analysed in the primary analysis. The two determinants of interest are (1) allocated intervention group and (2) time in months since end of the wash-in period (being zero for control hospitals), including the same co-variates as for neonatal severe infection/sepsis.
- Secondary Outcome Measures
Name Time Method Incidence of neonatal sever infections 12 months The study will assess the effect of the intervention among all infants on the cumulative incidence of neonatal severe infection/sepsis, laboratory-confirmed bloodstream infections, clinical sepsis and necrotising enterocolitis (NEC)
Incidence of neonatal morbidity 12 months The study will evaluate the composite outcome of major neonatal morbidity, defined as laboratory-confirmed sepsis, NEC, high-grade ROP, high-grade IVH, BPD or death during NICU stay, and the effect of the intervention in high-risk infants using a negative binomial model, adjusted for the cumulative incidence of the same endpoints in the year before start of the trial.
Trial Locations
- Locations (10)
University General Hospital Attikon
🇬🇷Attikí, Greece
University Hospital of Heraklion
🇬🇷Heraklion, Greece
Ioannina University Hospital
🇬🇷Ioánnina, Greece
Hippokration Hospital - Thessaloniki
🇬🇷Thessaloniki, Greece
Papageorgiou Hospital
🇬🇷Thessaloníki, 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
🇨🇭Saint-Gall, Switzerland
Universitätsspital Zürich - University Hospital Zurich
🇨🇭Zürich, Switzerland