Baby TAPE III

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

Summary

 The primary objective of this prospective, multi-center, masked, observational study is to ensure that users can effectively and reliably perform the critical tasks identified for human factor assessments for the babyTAPE in a device-use environment with infants aged 0-90 days, and to validate the comparability of the weight estimates obtained against the previous study’s (TAP02) regression model. Critical tasks being evaluated in this investigation include:

  1. Identification of the correct anatomic landmarks,
  2. Proper use and orientation of the babyTAPE device, and
  3. Accurate observation and recording of the babyTAPE device output.

The evaluation of these critical tasks will inform about the need for other risk reduction measures for safe use of the babyTAPE, and generate data that can be used to confirm the predictive performance and inform the effective use of the device. Additional data collected as part of this investigation will examine variability in device use between users.

Publications

  • Validation and human factor analysis study of an infant weight estimation device
    BMC Pediatrics • January 2020 Access article on PubMed. Abdel-Rahman SM, Paul IM, Delmore P, Chen JY, Mills M, Greenberg RG, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and ...

 

Label Change
Mercy babyTAPE received 510(k) clearance for use in estimating the body weight of pediatric patients from birth to 90 days using the Mercy TAPE device.