Validation and Human Factor Analysis of Mercy’s babyTAPE for Weight Estimation in Neonates and Young Infants

The babyTAPE device was developed to use head and chest circumference measures to predict infant weight. TAP03 objectives were to evaluate user performance of critical tasks in a device-use environment, confirm predictive performance, determine user subjective experience and define inter-rater reliability (IRR). A total of 486 infants were enrolled at three sites, stratified to include a cross-section of newborn ages and sizes including preterm. Infant height/weight were taken using a calibrated infant scale, and head/chest circumference measured with a masked reference tape and babyTAPE. Rater performance and confidence in results were reported. Actual weights were compared with estimations using the reference tape and babyTAPE. For both methods, there was tight correlation between actual and estimated weights and high IRR. Most raters found the babyTAPE device to be reliable and easy to use, and human factor error magnitude was reduced compared to the reference tape. No adverse device events were reported.

babyTAPE设备旨在通过测量头围与胸围来预测婴儿体重。本研究（TAP03）的核心目标为：评估设备使用场景下关键操作任务的用户表现，验证其预测性能，调研用户的主观使用体验，并明确评定者间信度（inter-rater reliability，IRR）。本研究在3家研究中心共纳入486名婴儿，采用分层抽样策略覆盖不同胎龄、不同体型的新生儿群体，其中包含早产儿。研究人员使用校准婴儿秤测量婴儿身高与体重，采用盲法参考软尺与babyTAPE设备分别测量头围与胸围。本研究记录了评定者的操作表现及对测量结果的信心程度。将参考软尺与babyTAPE设备得出的体重估算值与实际测量体重进行对比分析。结果显示，两种测量方式下，实际体重与估算体重均呈现极强相关性，且评定者间信度均处于较高水平。多数评定者认为babyTAPE设备操作简便且性能可靠，相较于参考软尺，该设备可有效降低人为因素导致的误差幅度。本研究未报告任何设备相关不良事件。