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临床试验/CTRI/2020/04/024933
CTRI/2020/04/024933尚未招募不适用

Identification Of Hemoglobin Variants By Newborn Screening

Department of Paediatrics1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
试验地点
1
主要终点
Proportion of different hemoglobin variants in the study population.

研究概览

简要总结

Hemoglobinopathies are considered important newborn screening targets. They are a result of structural abnormalities in the hemoglobin molecule.

Most studies in India and south east Asian countries have been done in antenatal periods or high risk groups. Identification of hemoglobin variants in the neonatal period helps us to do nearly interventions, education of family in terms of genetic and reproductive counseling and long term support of persistent anemias. There has been scarcity of published data on prevalence of various hemoglobin variants in northern India and their clinical implications. We attempt to study the proportion of structurally abnormal variants in neonatal population presenting to a tertiary care institution of  North India.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Healthy term neonates born at Lok Nayak Hospital on odd dates as per calender date.

排除标准

  • Newborns with history of previous blood transfusions
  • Newborns found to have HbA fractions of less than or equal to 15%(reflecting quantitative change in beta globin chain)
  • Newborns born on even days as per calender date of birth.

结局指标

主要结局

Proportion of different hemoglobin variants in the study population.

时间窗: at birth, 6 weeks and 14 weeks

次要结局

  • 1.Proportion of neonates having co-inherited variants(2.Proportion of parents and siblings carrying same variant)

研究者

申办方类型
Government medical college

研究点 (1)

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