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临床试验/NCT03947632
NCT03947632已完成不适用

Anthropometric Measurements in Children Having Transfusion-dependent Beta Thalassemia.

Aga Khan University0 个研究点目标入组 367 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
367
主要终点
Height in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

研究概览

简要总结

The aim of this study was to determine the anthropometric measurements in transfusion-dependent β-thalassemia children in Pakistan. The secondary aim was to correlate serum ferritin with the physical growth

详细描述

Material and methods

Setting The study was conducted at the Sections of Hematology and Clinical Chemistry in the Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, Pakistan during January 2013 to December 2014. Patient recruitment was conducted at a non-profit organization named Fatimid Foundation Karachi (FFK), which provides free of cost blood components to the patients with various blood disorders. There are more than 4000 registered patients of thalassemia and hemophilia at FFK.

Patient selection After informed consent from their parents, 367 pediatric patients (age 5-17 year) with transfusion-dependent β-thalassemia were recruited. All patients were diagnosed based on hemoglobin electrophoresis or high-performance liquid chromatography.

Data collection Detail history was collected by a trained research officer on a predetermined questionnaire. The following information was collected from medical records of the patients: demographics (age, gender, age at the time of diagnosis and at first transfusion), anthropometrics (height and weight), and clinical details (blood transfusion history, iron chelation, last pre-transfusion hemoglobin, and last serum ferritin levels).

Sample collection Five milliliter of blood samples were collected in two tubes (ethylenediaminetetraacetic acid and gel) at Fatimid foundation by a trained phlebotomist prior to blood transfusion to determine hemoglobin and serum ferritin.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with transfusion dependent beta thalassemia major
  • Age 5 to 17 years
  • Subjects with informed consent

排除标准

  • Age more than 17 years
  • Subjects who refused informed consent

结局指标

主要结局

Height in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

时间窗: Jan 2013 to Dec 2014

Height in meters will be recorded from medical records of the patients

Weight in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

时间窗: Jan 2013 to Dec 2014

Wight in kilograms will be recorded from medical records of the patients

Assessment of physical growth in transfusion-dependent β-thalassemia pediatric patients in Pakistan were recorded to assess growth rate

时间窗: Jan 2013 to Dec 2014

World health organization (WHO) 2007 growth charts were used for boys and girls to assess their physical growth. Body mass index (BMI) was computed as weight in kg/height in square meters (kg/m\^2). z-Score of height (h-SDS), weight (w-SDS), and BMI (BMI-SDS) were also calculated.

Serum ferritin levels and their association with z-Score of height

时间窗: Jan 2013 to Dec 2014

Correlation was assessed between height for age z-score and serum ferritin levels. Serum ferritin was measured by chemi-luminescent micro-particle immunoassay on Cobos® E-601. The association of z-Score of height with median serum ferritin levels was further confirmed by comparing these laboratory parameters in children with height z-scores \<2 with those with the z-score ≥2 using the Mann-Whitney test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bushra Moiz

Professor

Aga Khan University

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