The PTN’s Mercy Method™ tape study has locked its database containing information from 625 patients. Database lock means that all clinical trial data have been reviewed, queries have been resolved and issues addressed, and the database cannot be altered in any way. The trial concluded enrollment in April of this year.
The Mercy Method™—developed at Children’s Mercy Hospital in Kansas City—estimates weight based on measurements of arm length and upper arm circumference using a novel measuring device designed for simple fabrication and use. The goal of the device is to guide delivery of age-appropriate, weight-based interventions, which remain the most accurate approach to delivering care in children.
The Mercy Method™ tape could also help to ensure that proper drug doses are administered to children under special circumstances, such as emergency medical care situations or in third world countries that lack suitable scales. This study is the first device trial undertaken by the Pediatric Trials Network. The trial team is currently preparing the clinical study report and hopes to submit the final version of the report to the FDA by the end of this year.