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临床试验/NCT06908616
NCT06908616招募中不适用

The Prevalence of Ethnic Neutropenia in Neonates

Kaplan Medical Center1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年10月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Prevalence of Duffy null phenotype in neonates

研究概览

简要总结

This is a prospective observational study designed to assess the prevalence of the Duffy null phenotype (associated with ethnic neutropenia) in neonates born at Kaplan Medical Center. Blood samples will be collected from umbilical cords (non-invasively) to evaluate Duffy antigen expression. Data on ethnicity, perinatal factors, and routine blood counts at 9-12 months (when available) will also be collected to correlate phenotype with absolute neutrophil count (ANC).

详细描述

This is a prospective, observational cohort study designed to evaluate the prevalence of the Duffy null phenotype (Fya-/Fyb-) and its association with ethnic neutropenia in neonates born at Kaplan Medical Center in Israel. The Duffy null phenotype has been linked to lower peripheral neutrophil counts without increased infection risk in certain ethnic groups, a condition commonly referred to as benign ethnic neutropenia.

Cord blood samples will be collected from approximately 1,000 neonates during routine G6PD testing. An additional 3 mL will be obtained non-invasively from the umbilical cord after labour to determine the expression of Duffy antigens using serologic gel testing. Parental consent will be obtained, and information regarding ethnicity and family history of neutropenia will be collected.

Participants identified with the Duffy null phenotype will be followed through electronic health records to assess their neutrophil counts during routine blood screening at 9-12 months of age. The study will analyze associations between Duffy phenotype, neutropenia prevalence, and parental ethnic origin.

Findings may support improved diagnostic clarity around neonatal neutropenia and help reduce unnecessary interventions in otherwise healthy infants with genetically determined low neutrophil counts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates born at Kaplan Medical Center between 1.9.2024 and 31.12.2025
  • Parental informed consent obtained
  • Umbilical cord blood available for routine testing

排除标准

  • 未提供

结局指标

主要结局

Prevalence of Duffy null phenotype in neonates

时间窗: At birth (umbilical cord sample)

Percentage of neonates born with the Duffy null phenotype (Fya-/Fyb-) as determined by serologic gel-based testing.

次要结局

  • Prevalence of neutropenia in infants with Duffy null phenotype(9-12 months)
  • Association between parental ethnicity and Duffy null phenotype(At birth)

研究者

发起方
Kaplan Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tal Ben-Ami

Head of Pediatric Hemato-Oncology

Kaplan Medical Center

研究点 (1)

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