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在科特迪瓦约普贡整合床旁检测用于新生儿筛查及镰状细胞病早期护理 (STEP)

2026年9月30日 更新者：Swiss Tropical & Public Health Institute

在科特迪瓦Yopougon地区整合即时检验（POCT）用于新生儿筛查和镰状细胞病的早期护理

The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes.

The main questions it aims to answer are:

  • Does the intervention lower the number of SCD-related illnesses?
  • Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness?
  • Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)?

Researchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region.

Participants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Sickle cell disease (SCD) is an inherited life-threatening hematological disorder. Globally, every year, an estimated 300,000 children are born with sickle cell anemia (SCD - SS, homozygous form), the most severe form of SCD. About 75% of these births occur in Sub-Saharan Africa (SSA), of whom 50-90% die before their 5th birthday. In high income countries, it has been shown that newborn SCD screening and early comprehensive clinical interventions such as penicillin prophylaxis, safe blood transfusion, hydroxyurea and acute medical care, substantially reduces SCD morbidity and mortality. In low and middle-income countries (LMICs), the implementation of newborn SCD screening and early clinical interventions are largely poor.

The most commonly used newborn SCD screening techniques are isoelectric focusing (IEF), capillary electrophoresis (CE) and cation-exchange high performance liquid chromatography (HPLC). These techniques have a high cost, require skilled staff and a reliable electricity supply, and are therefore not suitable for remote settings in LMICs. In order to overcome these challenges, several point of care tests (POCTs) have been recently developed. The Gazelle Multispectral platform is the first SCD POCT that can be used to identify and quantify hemoglobin variants in newborns and people of any age.

In Côte d'Ivoire, as in many other African countries, the implementation of newborn SCD screening and early clinical interventions are lagging behind, and subsequently SCD morbidity and mortality are high. In this project, the investigators will implement a novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral POCT for newborn SCD screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care. The investigators will assess the effectiveness and cost of the multifaceted intervention. The effectiveness will be assessed based on the 2.5 - 3.5 years follow-up clinical records of SCD morbidity and mortality (clinical outcomes). The effectiveness data will be compared descriptively with historical data from the region, and used to inform SCD policy in Côte d'Ivoire. Historical data will be obtained from published literature in Cote d'Ivoire or nearby Countries such as Ghana. After three and a half years, the investigators aim to hand over the project to the Ministry of Health of Côte d'Ivoire for integration into its routine health care activities and potential nation-wide scale up.

研究类型

介入性

注册 (估计的)

120

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 科特迪瓦
      • Abidjan、科特迪瓦
        • 招聘中
        • Yopougon Millionnaire extension health center
        • 接触：
        • 接触：
      • Yopougon、科特迪瓦
        • 尚未招聘
        • Yopougon SCD Center of Excellence
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1秒 至 6个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Children aged 0 - 6 months old identified at selected health facilities within the study area
  2. Babies whose age plus the gestation period reaches 37 weeks or more
  3. Children who did not receive a blood transfusion within the past 90 days
  4. Children whose parents or guardians have consented to participate in the study by signing a consent form

Exclusion Criteria:

  1. Children already diagnosed with SCD
  2. Children that are participating in another clinical research project
  3. Children that are critically ill and require emergency treatment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Gazelle-Multispectral for newborn sickle cell disease screening; and early clinical interventions

A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care.
组合产品：Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions

A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
大体时间：Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up)

Note: The clinical outcomes are a summation of all the different parameters indicated. ''Morbidity'' includes vaso-occlusive crises (VOC); acute chest syndrome, stroke and other underlying causes of illness. ''Events'' include blood transfusions. ''All cause hospitalizations'' are a result of ''morbidities''.
Baseline, 1 year, 2 years, 3 years, and 3.5 years
The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
大体时间：Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Number of SCD related morbidity and events i.e. i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1b. Morbidity incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to one of the following SCD related morbidity and events: i) vaso-occlusive crises (VOC); ii) acute chest syndrome (ACS); iii) stroke; iv) blood transfusions; v) all cause hospitalizations

1c. All-cause mortality rate (at the end of 1, 2, 3 and 3.5 years of follow-up)
Baseline, 1 year, 2 years, 3 years, and 3.5 years

次要结果测量

结果测量
措施说明
大体时间
The implementation costs and the cost-effectiveness of a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:
大体时间：Baseline, 1 year, 2 years, 3 years, and 3.5 years

1a. Total financial and economic costs associated with program roll out

1b. Costs per child screened with POCT

1c. Costs per SCD screen positive child

1d. Annual costs associated with early comprehensive SCD care

1e. Number of morbidity and mortality averted

1f. Cost per morbidity and mortality averted by the multifaceted intervention

Note: Outcomes 1a. to 1d. indicate and represent ''implementation costs''. Outcome 1e. indicates and represents ''effectiveness''. Outcomes 1f. refers to ''cost effectiveness''.
Baseline, 1 year, 2 years, 3 years, and 3.5 years
The budget impact (per year) associated with early comprehensive SCD care for all children who test positive in Côte d'Ivoire
大体时间：Baseline, 1 year, 2 years, 3 years, and 3.5 years

1. Annual costs associated with early comprehensive SCD care for all children who test positive
Baseline, 1 year, 2 years, 3 years, and 3.5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Swiss Tropical & Public Health Institute

合作者

Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Novartis Pharma AG, Switzerland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月27日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2026年2月24日

首先提交符合 QC 标准的

2026年3月18日

首次发布 (实际的)

2026年3月23日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AO_2025-00105

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data (IPD) are available on request to bona fide researchers via the Swiss Center for Scientific Research in Côte d'Ivoire (CSRS), Swiss Tropical and Public Health Institute (Swiss TPH) and Novartis Pharma AG. Data can be granted on a case-by-case basis jointly by the project leaders at the CSRS, Swiss TPH and Novartis. This process is designed to protect participants' confidentiality, which might be compromised if data were publicly available. Requests to access data should be made to Prof. Dr. Benjamin Koudou (CSRS) via guibehi.koudou@csrs.ci or Dr. Acellam Charles Abongomera (Swiss TPH) via charles.abongomera@swisstph.ch or to Novartis according to the criteria and processes described on the Clinical Study Data Request website ClinicalStudyDataRequest.com

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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