跳至主要内容
临床试验/NCT01507090
NCT01507090已完成不适用

Taking the Guesswork Out of Pediatric Weight Estimation (TAPE): Validation of the Mercy TAPE

Susan Abdel-Rahman3 个研究点 分布在 1 个国家目标入组 642 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
642
试验地点
3
主要终点
Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)

研究概览

简要总结

In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. Numerous weight estimation strategies have been described but each has limitations. Investigators at Children's Mercy Hospitals and Clinics recently developed a weight estimation method and tool that addresses the limitations of previously published methods. This study is intended to validate the device in a population of children 2 months to 16 years of age.

详细描述

In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. The most conspicuous of these settings can be found in developing countries where many medical clinics lack suitable scales to obtain accurate infant and child weights. Though resource restrictions are less of an issue in developed countries, scenarios still exist where weight assessment is problematic. For example, accurate estimates of a child's weight are rarely available during emergency or trauma situations, and in some in-patient settings (e.g. critical care units, orthopedic clinics) obtaining an accurate patient weight can be impaired by the presence of external hoses, tubing, casts, and/or other medical equipment. Irrespective of the environment, the challenge that each of these settings present is the same; namely, the provision of age-appropriate, weight-based interventions which remain the most accurate approach to delivering therapy in children. Thus, techniques which permit accurate weight estimation address a critical medical need in both developing and developed countries.

Numerous weight estimation strategies have been described with each used to varying degrees in clinical practice. Many of the published techniques have distinct advantages. For example; simple age-based equations can be used without the need for reference materials, strategies that utilize preprinted tables or tools limit the risk of calculation errors. Other techniques present unnecessary complexities for the end-user including; the need for subjective assessments of habitus, the requirement to solve exponential equations, the call for multiple formulae delineated by age bracket, or the reliance on one or more reference charts. Irrespective of their simplicity or complexity, almost all of the reported techniques have significant limitations. Relatively few methods have been evaluated in pediatric populations of varying races, ethnicities and nationalities and essentially no single previously described method provides accurate estimates of weight across broad age- and weight-bands.

Apart from parental recall which can vary in accuracy, the most commonly used strategies for estimating weight rely on the child's age, length, or a combination of the two parameters. While simple and easy to integrate into a weight estimation technique, age based strategies fail to account for the extremes of body composition and stature that are observed in children of the same age. Similarly, length based strategies do not take into consideration that two children of the same height may demonstrate markedly discrepant weights based on underlying nutritional status (e.g. malnourished, underweight, overweight, obese). Consequently, many of the currently available weight estimation strategies perform well in only a small subset of children. As such, there remains a critical need for weight estimation methods that are accurate across a wide range of pediatric ages, weights, lengths, nationalities and body compositions despite the relative abundance of strategies that already exist.

Investigators at Children's Mercy Hospitals and Clinics recently developed and validated a weight estimation method (the Mercy MethodTM) that addresses the principal limitations of previously published methods, requires no subjective assessment and performs robustly independently of age and length over a broad range of weights. As with other strategies, the Mercy Method incorporates growth velocity but uses humeral length as a surrogate for total body length. Total body length will be discrepant depending on whether the measurement is obtained with the child standing or lying down and can be difficult to obtain in a child who is uncooperative or obtunded. The Mercy Method also incorporates body habitus as a quantitative variable which improves the accuracy of the overall length-based weight estimate and removes the subjective nature of categorizing the child's body type into one of a few alternatives (e.g. "slim," "average," or "heavy"). By developing a model with these considerations in mind we were able to expand the age range to which our weight estimation method can be applied and remove length restrictions which are typically imposed because of the disproportionate increase in weight-for-height observed as children get older.

In brief, demographic and anthropometric data on children 2 months to 16 years of age were extracted from the NHANES database and individual datasets were randomly assigned into a method development (n=17,328) or a method validation (n=1,938) set. Humeral length (HL) and mid-upper arm circumference (MUAC) were used to develop a weight estimation method by 1) collapsing length and habitus measurements into discrete bins, 2) examining the median population weight for each bin-pair, 3) statistically weighting the bin-pairs for age and sample size, and 4) calculating a fractional weight for each HL and MUAC. An individual weight estimate is generated by the simple addition of the MUAC and HL fractional bin value that corresponds to that individual child's measurements. The predictive performance this method was evaluated using the internal validation set and compared with the performance of 13 previously published weight estimation methods applied to the same data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age between 2 months and 16 years of age
  • capable of having the measurements performed
  • parent or legal guardian is willing and able to provide verbal permission and, when appropriate, the participant has provided verbal assent to participate.

排除标准

  • unwilling to participate in the study procedures
  • known or apparent limb deformities
  • presence of any external medical equipment attached to the child
  • underlying pathological condition that would produce abnormal body composition for age (e.g. edema)
  • underlying pharmacologic management that would produce abnormal body composition for age (e.g. chronic oral corticosteroid use)
  • In the opinion of the physicians providing patient care and those conducting the study, there are real or perceived contraindications for inclusion as a participant in the study

结局指标

主要结局

Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.

Predictive Performance of the Mercy TAPE (Slope)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.

Predictive Performance of the Mercy TAPE (Intercept)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.

Predictive Performance of the Mercy TAPE (Mean Error)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Predictive Performance of the Mercy TAPE (Mean Percentage Error)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Predictive Performance of the Mercy TAPE (Corelation Coefficient)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Predictive Performance of the Mercy TAPE

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.

Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)

时间窗: study day 1

Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.

次要结局

  • Inter-rater Reliability for the 2D and 3D Mercy TAPEs.(study day 1)
  • Device Print Batch Variability(study day 1)
  • Predictive Performance of the Mercy Method (Intercept)(study day 1)
  • Predictive Performance of the Mercy Method (Slope)(study day 1)
  • Predictive Performance of the Mercy Method (Percent of Participants)(study day 1)
  • Predictive Performance of the Mercy Method (Mean Error)(study day 1)
  • Predictive Performance of the Mercy Method (Mean Percentage Error)(study day 1)
  • Predictive Performance of the Mercy Method(study day 1)

研究者

发起方
Susan Abdel-Rahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Susan Abdel-Rahman

Professor of Pediatrics

Children's Mercy Hospital Kansas City

研究点 (3)

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