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临床试验/NCT01718769
NCT01718769已完成不适用

Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.

研究概览

简要总结

Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file.

Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.

A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children between 1 and 6 years old
  • children treated at the clinics participating in the study

排除标准

  • Lack of consent or lack of Hebrew proficiency
  • children that not receiving treatment in day hospitalization at any hospital

结局指标

主要结局

Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.

时间窗: one year

The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.

A change in frequency of recording of nutritional diagnoses for malnutrition; abnormal growth curves, FTT (Failure To Thrive), underweight, overweight, and obesity.

时间窗: Baseline and after 1 year

The following will be evaluated before and after conducting the study: % of children \< percentile 5, % of children \> percentile 85, % of children \> percentile 95, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER.

次要结局

  • To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children(one year)
  • To evaluate the frequency of malnutrition among children in the community in the study clinics.(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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