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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,080
- 试验地点
- 34
- 主要终点
- Neonatal severe infection/sepsis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
- •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.
排除标准
- •1 Site level
- •a. Participation in other research that could directly influence the study intervention or outcomes.
- •a. Average StSC duration already exceeding 18 hours per day.
- •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.
结局指标
主要结局
Neonatal severe infection/sepsis
时间窗: 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
时间窗: 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.
次要结局
- Incidence of neonatal sever infections(12 months)
- Incidence of neonatal morbidity(12 months)