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

PENTA Foundation3,080 enrolled

Overview

NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. The trial includes a baseline period, a wash-in phase, and a staggered randomisation approach. The primary focus of the NeoDeco study is on high-risk preterm infants born at less than 32 weeks' gestational age, a population particularly vulnerable to hospital-acquired infections and sepsis during their initial hospital stay. By investigating hospital-acquired infections specifically, the study targets the period during which optimised KC practices are likely to have the most significant impact.

NeoDECO trial is a cluster-randomised study involving up to 24 neonatal units (clusters) across five European countries: Switzerland, Italy, Greece, Spain, and the United Kingdom. Each participating neonatal unit constitutes a cluster, with the intervention implemented at the unit level. The study is structured into two staggered. Within each stagger, sites are randomised 1:1 to either the intervention arm or control arm (standard care). Control Arm (Standard Care): Sites randomised to the control arm will continue with current routine practices, which might include kangaroo care (KC), skin-to-skin contact (StSC), infection prevention and control measures, and the treatment of severe infections or neonatal sepsis. While KC is already part of routine care in all participating units, there are no structured efforts in place to ensure adherence to international best practice guidelines. Intervention Arm (Optimised KC): Sites in the intervention arm will implement optimised KC in line with internationally recognised best practice recommendations. The intervention is comprised of two key components: Component 1: Skin-to-Skin Contact (StSC) for Optimised KC This component defines the desired frequency, duration, and initiation timing of early, repeated, and sustained StSC that characterise optimised KC in high-technology neonatal environments where KC is already offered. Component 2: Implementation Support This component focuses on engaging clinical staff responsible for KC delivery. Implementation support includes training, ongoing support, and tools to embed optimised KC into routine practice. The goal is to facilitate sustained practice change through staff empowerment and structured implementation strategies. Following randomisation, sites allocated to the intervention arm will undergo an intervention period of up to 10 months. All sites-regardless of allocation-will collect clinical data and biological samples from all consented high-risk infants present in the unit on the day of the assessment. The collected samples will be analyzied centrally and help monitor colonisation and infection patterns over time, with particular focus on the incidence of hospital-acquired infections. To evaluate the fidelity and quality of the intervention delivery, one representative intervention site from each participating country will be selected for enhanced data collection and engagement with the implementation team. These sites will participate in more detailed assessments related to: fidelity of intervention delivery, implementation strategies used, acceptability, appropriateness, and feasibility of optimised KC. At the conclusion of the study, all control sites will receive full support and training to implement optimised KC using the tested implementation strategies. This ensures equitable access to the intervention benefits across all participating units and supports the potential scale-up of optimised KC practices beyond the trial period.

Eligibility

Sex: ALLMax age: 32 Weeks

Medical Language ↔ Plain English

INCLUSION CRITERIA 1\. Site level 1a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation). 1b. Minimum capacity of 12 beds. 1c. Access to a -70 to -80°C freezer for storage of research samples 1d. Willing to implement optimised KC if allocated to the intervention group. 1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \>67% of the minimum expected target duration, if allocated to the intervention arm. 1f. Prepared to implement NeoIPC surveillance. 1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate. 2. Infant level 2a. All high-risk infants (born at \<32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth. EXCLUSION CRITERIA 1 Site level 1. a. Participation in other research that could directly influence the study intervention or outcomes. 2. a. Average StSC duration already exceeding 18 hours per day. 3. a. Anticipated major changes in resistant bacterial colonisation pressure during the study 2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.

Locations (24)

Aglaia Kyriakou Children's Hospital

Athens, Greece

RECRUITING

University General Hospital Attikon

Attiki, Greece

COMPLETED

University Hospital of Heraklion

Heraklion, Greece

COMPLETED

Ioannina University Hospital

Ioannina, Greece

COMPLETED

University General Hospital of Patras

Pátrai, Greece

RECRUITING

Hippokration Hospital - Thessaloniki

Thessaloniki, Greece

COMPLETED

Papageorgiou Hospital

Thessaloniki, Greece

COMPLETED

Azienda Ospedaliera Universitaria S.Anna di Ferrara

Ferrara, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Modena

Modena, Italy

RECRUITING

Ospedale Universitario Policlinico Paolo Giaccone

Palermo, Italy

RECRUITING

...and 14 more locations

Outcomes

Primary Outcomes

Neonatal severe infection/sepsis defined as an episode of one of three infectious entities as registered in the surveillance system

The clinical primary endpoint neonatal severe infection/sepsis will be assessed through NeoIPC surveillance. Neonatal severe infection/sepsis is defined as an episode of one of three infectious entities as registered in the surveillance system: clinical sepsis, a laboratory-confirmed bloodstream infection or pneumonia, where the first symptoms occur on day 3 after admission or later (admission day is day 1) in high-risk infants. For infants admitted directly after birth episodes first symptoms of infection occur after 72 hours of life.

Time frame: 12 months

Secondary Outcomes

Resistant bacterial colonisation defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS

Resistant bacterial colonisation is defined as the detection of one or more pre-specified bacterial resistance genes in a stool sample during a PPS. It will be assessed in high-risk infants through targeted resistome analysis (detection of resistance genes) using PCR-based genomics on stool samples collected during regular PPS. A subset of samples will undergo additional testing, including quantitative cultures, whole genome sequencing, and untargeted shotgun metagenomic sequencing. An infant is considered colonised if PCR identifies genes from at least one of the following highly prevalent resistance gene families in a stool sample: CTX-M (extended-spectrum beta-lactamase), VIM, NDM, KPC, IMP, or OXA-48 (carbapenemase), and vanA or vanB (vancomycin resistance)

Time frame: 12 months

Surveillance-based neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data.

Cumulative incidence of neonatal severe infection/sepsis based on cluster-aggregated NeoIPC Surveillance data. The numerator is the number of high-risk infants with at least one episode of neonatal severe infection/sepsis registered in NeoIPC Surveillance during a study period. The denominator is the total number of high-risk infants registered in NeoIPC Surveillance during the same period.

Time frame: 12 months

Infection outcomes assessed with separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis

Will be assessed the separate cumulative incidences of the three components of the primary outcome and necrotising enterocolitis (NEC): * Clinical sepsis * LC-BSI * Pneumonia * NEC

Time frame: 12 Months

Infection outcomes defined with incidence rate number

Will be also define incidence rates of: * Neonatal severe infection/sepsis * LC-BSI * Clinical sepsis Incidence rate is the number of infection episodes divided by the total time the infant contributed to a study period, expressed in infant days. Multiple episodes per infant can be included.

Time frame: 12 Months

Major non-infection neonatal morbidity collected aggregated at the cluster level, separately for the baseline and intervention period, and is therefore a unit-level endpoint

Major non-infection neonatal morbidity includes type 1 retinopathy of prematurity (ROP), high-grade intraventricular haemorrhage (IVH), cystic periventricular leukomalacia (PVL) and/or bronchopulmonary dysplasia (BPD) at 36 weeks' post-menstrual age, as collected in the unit-level data collection. Cumulative incidence of major non-infection neonatal morbidity is the number of high-risk infants with a first diagnosis of any of the major morbidity items divided by the total number of high-risk infants admitted at a site during a study period. It is collected aggregated at the cluster level, separately for the baseline and intervention period, and is therefore a unit-level endpoint.

Time frame: 12 months

Neonatal unit length of stay: total number of calendar days an infant was hospitalised on the neonatal unit during the study period

Neonatal unit length of stay is the total number of calendar days an infant was hospitalised on the neonatal unit during the study period, independent of whether these are accrued as part of a primary or re-admission.

Time frame: 12 months

Antibiotic treatment recording through both NeoIPC Surveillance and clinical data collection in PPS

Sites will record antibiotic receipt during admission until discharge in infants with informed consent in place through both NeoIPC Surveillance and clinical data collection in PPS. Days on antibiotic treatment is the total number of calendar days an infant received one or more antibiotics divided by the total days the infant contributed to a study period, expressed in infant days.

Time frame: 12 months

StSC duration in hours and minutes in the preceding 24 hours

Sites will record StSC duration in hours and minutes in the preceding 24 hours in all infants with informed consent in place and hospitalized at the day of a weekly PPS.

Time frame: 12 months

StSC target attainment: the minimum expected target duration of StSC is a site-specific total daily duration of StSC to be provided per infant per day

The minimum expected target duration of StSC is a site-specific total daily duration of StSC to be provided per infant per day. The proportion of infants receiving the minimum expected target duration of StSC is the number of infants contributing to a site's PPS that received the local minimum expected target duration of StSC divided by the total number of infants contributing to the same PPS.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (24)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts