An interventional study of Optimised kangaroo care in Infection, Bacterial and Infection Prevention, sponsored by PENTA Foundation. Recruiting at 24 sites in 5 countries. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by PENTA Foundation · Not applicable, Interventional, and Supportive care
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.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's planned enrollment of 3,080 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →PENTA Foundation is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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
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 . These infants contribute to cluster-aggregated outcomes.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.,
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
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
Health economic analysis assessed with cost-effectiveness of optimised KC and implementation approach.
To assess cost-effectiveness of optimised KC and the implementation approach.
Time frame: 12 months
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Plan to share: No
Started May 2024 (actual). Primary completion is estimated for Apr 2026, 23 months after the start.
Of 56 non-industry interventional studies with no phase under Bacterial Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 23 months is close to that.
Counting every sponsor, half of 60 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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