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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infection, Bacterial
• Intervention / Treatment: Behavioral: Optimised kangaroo care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 11440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federica D'Ambrosio; Phone Number: +39 378 302 9089; Email: federica.dambrosio@pentafoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	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.,
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: PENTA Foundation
• Collaborators: Charite University, Berlin, Germany; University of Zurich; UMC Utrecht; Universiteit Antwerpen; St George's, University of London; European Clinical Research Alliance for Infectious Diseases (ECRAID)
• Investigators: Study Chair: Julia Bielicki, PhD, St George's, University of London

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Surveillance; Cluster; Nosocomial Infection; Implementation science; Bacterial; Neonatal unit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: NeoDeco

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No