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:
- Identification of the correct anatomic landmarks,
- Proper use and orientation of the babyTAPE device, and
- 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.
Susan M. Abdel-Rahman, PharmD
Children's Mercy, Kansas City, MO
Pharmacokinetic and Pharmacodynamic Core Laboratory