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临床试验/ACTRN12611000596909
ACTRN12611000596909已完成未知

The socioeconomic, biochemical, and nutritional determinants of anaemia and micronutrient status among 12-23 month old children living in two districts of rural Karntaka, South India

Haematology Research Unit, St John's Research Institute, St Johns National Academy of Health Sciences, Bangalore, India0 个研究点目标入组 420 人开始时间: 2011年6月9日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
420

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
12 Months 至 23 Months(—)
性别
All

入选标准

  • Child born between 12 and 23 months 30/31 days prior to the date of sampling, living in selected villages served by randomly selected subcentres of the study Primary Health Centres.
  • Where birth records are unavailable or carers are unaware of the specific birth date, local calendars will be used to identify important dates (eg festivals), and we will ask whether children were born before/ after these dates. We will accept ages and birth dates to within the month.

排除标准

  • Any child without a primary carer (mother, father, relative or responsible adult defined as older than 18 years). Where the mother is the primary carer but is younger than 18 years old, the father will be asked to provide additional consent for the child’s involvement in the study if he is older than 18 years old. Where both parents are younger than 18 years, consent attained from the mother will be confirmed by a responsible senior member of the village.
  • Any child living with a carer whom is unwilling or unable to give informed consent for participation in the study.
  • Any child currently suffering from an acute medical illness, defined as:
  • a.Fever – temperature >38.0 degrees Celsius
  • b.Tachypnoea – respiratory rate >45 resps/ minute
  • c.Diarrhoea > 4 soft/ watery stools per day, or bloody diarrhoea.
  • d.Dehydration – signs of moderate – severe dehydration, including sunken eyes, dry mucous membranes, fewer than 4 wet nappies per day, raised skin turgor, or acidotic breathing.
  • e.Drowsiness, excessive fatigue, lethargy.
  • f.Any previous blood transfusion.
  • g.Any other acute illness requiring immediate medical attention.
  • All children will be screened by a medical officer prior to enrolment. Children meeting the above criteria will be transported to the Primary Health Centre for immediate treatment.
  • Child refusing cooperation with the study team despite 15 minutes comforting by carer and study team – such children may be visited again later if the carer agrees.
  • The total number of children eligible, the number found to be unwell, the number whose carers are not willing to participate, and the total number finally enrolled in the study will be reported.

研究者

发起方
Haematology Research Unit, St John's Research Institute, St Johns National Academy of Health Sciences, Bangalore, India

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