Remote Biomonitoring (RBM) for Temperature Surveillance of Mothers and Newborns: Pre-clinical and Clinical Evaluation

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Temperature Change, Body
Interventions
DEVICE

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.

Trial Locations (1)

560034

St. John's Research Institute, Bangalore

All Listed Sponsors
collaborator

Indian Institute of Science

OTHER_GOV

lead

St. John's Research Institute

OTHER

NCT04608565 - Remote Biomonitoring (RBM) for Temperature Surveillance of Mothers and Newborns: Pre-clinical and Clinical Evaluation | Biotech Hunter | Biotech Hunter