250
Participants
Start Date
May 31, 2014
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
Remote biomonitoring sensor device
Same as described in arm descriptions. Safety was ensured by getting radiant warmer and multichannel probe examined and services by the biomedical engineering department; calibration certificates were obtained and these were used routinely in care of other neonates. An adverse event reporting and resolution protocol for the wearable sensor devices to capture number and severity of adverse events; individual clinical management and feedback for changes into device design. Adverse events recorded were: dermatitis, infection, thermal injury, radiation injury, device leak/burst and others.
St. John's Research Institute, Bangalore
Indian Institute of Science
OTHER_GOV
St. John's Research Institute
OTHER