Novel Screening Tools For the Evaluation and Management of Malnourished Children in the Developing World
研究概览
地位
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The investigators plan to recruit 10 overweight or obese adolescents followed by the Duke Division of Pediatric Endocrinology and Diabetes. Investigators will review the electronic medical records of potential participants identified by their primary providers to ensure they meet the eligibility criteria.
The investigators will also recruit 10 infants hospitalized in the Duke Transitional Care Nursery and will review the electronic medical records of potential participants identified by their primary providers to ensure they meet the eligibility criteria.
描述
Inclusion Criteria:
Overweight or Obese: Inclusion criteria for these subjects will include:
- Age 8-17 years;
- male or female; and
- BMI >85% for age.
Premature or Small for Gestational Age: Inclusion criteria for these subjects will include:
- Age <1 year,
- male or female,
- small for gestational age or intra-uterine growth restriction (IUGR) defined by the 9th revision of the International Classification for Diseases OR
- prematurity as defined by the 9th revision of the International Classification for Diseases.
Exclusion Criteria:
- Exclusion criteria include refusal or inability to provide samples of blood.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
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Overweight or Obese
Children being seen in consultation or follow-up within the Duke Division of Pediatric Endocrinology and Diabetes who are overweight or obese.
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Premature or Small for Gestational Age
Infants hospitalized in the Duke Transitional Care Nursery who were born prematurely or small for gestational age.
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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 |
|---|---|---|
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Variation between results of novel screening tool and standard ELISA
大体时间:1 year
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The 2-D diffusion POCT will be validated against commercial ELISA assays, run in the Duke Molecular Physiology Institute laboratory, using recombinant human leptin and high molecular weight adiponectin from blood samples.
Dose-response curves will be generated using analyte-spiked buffer.
The dose-response data from 20 separate dose-response dilutions will be fit with the five-parameter logistic (5-PL) curve.
The coefficients of variation (inter and intra-assay) for standard ELISAs for leptin and adiponectin assays are less than 10%.
The investigators will analyze the results of each assay in addition to the means and standard deviations of the POCT assays and ELISAs.
The POCT assay will be considered valid if the variation from the ELISA is less than 20% and if there is no statistically significant difference between the means and standard deviations.
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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