TAP03 Participant Data Collection in Validation and Human Factor Analysis of Mercy’s babyTAPE for Weight Estimation in Neonates and Young Infants

TAP03 Participant Data Collection data
Study Description
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. The TAP03 study enrolled a total of 486 infants, between 0 to 90 days of age at enrollment and stratified by post-menstrual age in weeks.