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

Infection, Bacterial Clinical Trial

— NeoDeco  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993442
• Other study ID #: NeoDeco
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: September 2026

Study information

• Verified date: January 2024
• Source: PENTA Foundation
• Contact: Federica D'Ambrosio
• Phone: +39 378 302 9089
• Email: federica.dambrosio[@]pentafoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The NeoDECO trial is a cluster randomised trial of 24 neonatal units in 5 European countries (Switzerland, Italy, Greece, Spain and United Kingdom). Each neonatal unit/site is a cluster and the intervention is applied at the unit-level.

Sites will be grouped into staggers. Within each stagger, sites will be randomised to the intervention or control (standard care) arm. The randomisation will occur at the end of the baseline period which is identical for all sites. Intervention sites will then undergo a 2-month wash-in phase during which time they will receive training and workshops on implementation strategies for optimised KC.

Following the wash-in phase, the intervention period for intervention sites will last 12 months, during which time optimised KC (defined as early, repeated and sustained StSC) will be continuously implemented.

All sites (both intervention and control arm) will carry out a baseline data collection phase of clinical surveillance and colonisation assessments. All sites will also conduct weekly collection of skin swabs and stool samples from all babies in the unit on the day of the assessment.

In addition, one representative site per country of the intervention arm will be selected for further in-depth engagement and data collection with the implementation team to gather further 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 11440
• Est. completion date: September 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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 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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infections

Intervention

Behavioral:
• 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.,

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
PENTA Foundation	Charite University, Berlin, Germany, European Clinical Research Alliance for Infectious Diseases (ECRAID), St George's, University of London, UMC Utrecht, Universiteit Antwerpen, University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of SSIs	The study will explore the effect of the intervention among high-risk infants and all infants on cumulative incidences of SSIs, including superficial, deep or organ-space SSI, pneumonia (including VAP) and DAIs.	12 months
Other	Prevalence of breastfeeding	The study will compare prevalence of breastfeeding and mother's milk intake over time as well as human milk intake among high-risk infants and all infants in both groups.	12 months
Other	Incremental cost-effectiveness ratio (ICER)	The incremental cost-effectiveness ratio (ICER) of the intervention compared to the standard care using indicators from the trial outcomes will be calculated to estimate a range of ICERs, including the incremental cost per case of infection averted, cost per life-year gained, and cost per disability-adjusted life-years (DALYs) averted.	12 months
Other	Budget impact of the intervention arm	A sensitivity analysis to assess the robustness of cost-effectiveness analyses results to changes in assumptions or inputs will be performed. This may entail testing various scenarios or different assumptions about the costs or benefits of optimised KC. Further, the budget impact of scaling-up the intervention's coverage for the health systems of the countries included in the study will be estimated, if proved effective and cost-effective.	12 months
Primary	Neonatal severe infection/sepsis	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).	12 months
Primary	Resistant bacterial colonisation over time	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.	12 months
Secondary	Incidence of neonatal sever infections	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)	12 months
Secondary	Incidence of neonatal morbidity	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.	12 months

External Links

•   NeoDeco study is part of the NeoIPC project funded by the European Commission.