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

NCT04608565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-10-29

No results posted yet for this study

Summary

Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design. The device underwent multiple iterations in product design and engineering based on user-feedback and then following pre-clinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care, teaching hospital in Bangalore, India. Clinical trial phases I and IIa {studies/pilot studies designed to demonstrate clinical efficacy or biological activity ('proof of concept' studies)} for evaluation of safety and efficacy were undertaken in the following sequence: first with healthy adult volunteers; then healthy mothers; healthy babies; stable babies in the Neonatal intensive care unit (NICU) and then a baby with morbidities. Time-stamped skin temperatures obtained at 5-minute intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice, radiant warmer and multimodal sensor

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.

Sponsors & Collaborators

  • Indian Institute of Science

    collaborator OTHER_GOV

  • St. John's Research Institute

    lead OTHER

Principal Investigators

  • Prem K Mony, MD · St. John's Research Institute

  • Prashanth Thankachen, PhD · UCAM Ltd.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608565 on ClinicalTrials.gov