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

NCT04608565 | Completed

• 1 other identifier: StJohnRI
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Newborns; Biomonitoring; Sensor; Device; Remote

Outcome Measures

Primary Outcomes (1)

• Design, development and testing of a wearable sensor device for remote biomonitoring (RBM) of body temperatures in mothers and newborns

  We describe the design, development and testing of a wearable sensor device for remote biomonitoring (RBM) of body temperatures in mothers and newborns in southern India.

  May 2014-Mar 2015

Study Arms (1)

Remote biomonitoring sensor device

OTHER

250 readings for a power of 80% and to detect a 5% difference in measurements with 95% confidence interval from mothers and newborns was ascertained. Once 3 probes were strapped (radiant warmer, RBM device and multichannel), a waiting period of 10 minutes for temperature stabilization was given. First RBM device \& multichannel probe provided readings continuously (every few seconds); Then radiant warmer probe and manual thermometer readings were taken every 15 minutes for 5 timings: 0, 15, 30, 45 and 60 minutes. Participant safety for newborns was ensured following routine appropriate care protocols.

Device: Remote biomonitoring sensor device

Interventions

Remote biomonitoring sensor device 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.

Remote biomonitoring sensor device

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mothers 15-44 years
• Neonates 1-7 days who were healthy and of normal weight from postnatal ward
• Neonates 1-7 days who were stable from neonatal intensive care unit above 1500 grams

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• St. John's Research Institute: lead
• Indian Institute of Science: collaborator

Study Sites (1)

St. John's Research Institute

Bangalore, Karnataka, 560034, India

Location

Related Publications (20)

• Varkey P, Horne A, Bennet KE. Innovation in health care: a primer. Am J Med Qual. 2008 Sep-Oct;23(5):382-8. doi: 10.1177/1062860608317695.

  PMID: 18820143 BACKGROUND

• Christensen CM, Bohmer R, Kenagy J. Will disruptive innovations cure health care? Harv Bus Rev. 2000 Sep-Oct;78(5):102-12, 199.

  PMID: 11143147 BACKGROUND

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Million Death Study Collaborators; Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, Shet A, Ram U, Gaffey MF, Black RE, Jha P. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010 Nov 27;376(9755):1853-60. doi: 10.1016/S0140-6736(10)61461-4. Epub 2010 Nov 12.

  PMID: 21075444 BACKGROUND

• Yilmaz T, Foster R, Hao Y. Detecting vital signs with wearable wireless sensors. Sensors (Basel). 2010;10(12):10837-62. doi: 10.3390/s101210837. Epub 2010 Dec 2.

  PMID: 22163501 BACKGROUND

• Ramdorai A, Herstatt C. Frugal innovation in healthcare: how targeting low-income markets leads to disruptive innovation. Springer International Publishing Switzerland. 2015

  BACKGROUND

• Registrar General of India. Sample Registration System Bulletin. Vol 49, No. 1. New Delhi, India: Government of India. 2014

  BACKGROUND

• Chen W, Dols S, Oetomo SB, et al. Monitoring body temperature of newborn infants at neonatal intensive care units using wearable sensors. BodyNets'2010, September 10-12, 2010, Corfu Island, Greece.

  BACKGROUND

• Smith J. Methods and devices of temperature measurement in the neonate: a narrative review and practice recommendations. Newborn & Infant Nursing Reviews 2014: 64-71

  BACKGROUND

• USAID. Report to Congress: Health-Related Research and Development Activities at USAID (HRRD), May 2006

  BACKGROUND

• Government of India. The Medical Devices Regulation Bill, 2006 (No XX of 2006). Department of Science & Technology, New Delhi.

  BACKGROUND

• Thyssen JP, Menne T. Metal allergy--a review on exposures, penetration, genetics, prevalence, and clinical implications. Chem Res Toxicol. 2010 Feb 15;23(2):309-18. doi: 10.1021/tx9002726.

  PMID: 19831422 BACKGROUND

• Lund, C. Medical Adhesives in the NICU. Newborn & Infant Nursing Reviews 2014: 160-165

  BACKGROUND

• Rao H, Saxena D, Kumar S, et al. Low power remote neonatal temperature monitoring device. 7th International Conference on Biomedical Electronics and Devices (BioDevices 2014). 3-6 March 2014, Angers, France.

  BACKGROUND

• Yock P. Needs-based innovation: the biodesign process. BMJ Innov 2015;1:3

  BACKGROUND

• Lansisalmi H, Kivimaki M, Aalto P, Ruoranen R. Innovation in healthcare: a systematic review of recent research. Nurs Sci Q. 2006 Jan;19(1):66-72; discussion 65. doi: 10.1177/0894318405284129.

  PMID: 16407603 BACKGROUND

• Basem El-Haik B, Mekki KS. Medical device design for six sigma: a road map for safety and effectiveness.

  BACKGROUND

• Zhu Z, Liu T, Li G, Li T, Inoue Y. Wearable sensor systems for infants. Sensors (Basel). 2015 Feb 5;15(2):3721-49. doi: 10.3390/s150203721.

  PMID: 25664432 BACKGROUND

• Verschaeve L. Genetic damage in subjects exposed to radiofrequency radiation. Mutat Res. 2009 Mar-Jun;681(2-3):259-270. doi: 10.1016/j.mrrev.2008.11.002. Epub 2008 Nov 27.

  PMID: 19073278 BACKGROUND

• El-Noush H, Silver KL, Pamba AO, Singer PA. Innovating for women's, children's, and adolescents' health. BMJ. 2015 Sep 14;351:h4151. doi: 10.1136/bmj.h4151. No abstract available.

  PMID: 26371217 BACKGROUND

Related Links

• India and the MDGs: Towards a sustainable future for all.
• Electromagnetic fields and cancer
• Safety concerns with Li-ion

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prem K Mony, MD

  St. John's Research Institute

  PRINCIPAL INVESTIGATOR

• Prashanth Thankachen, PhD

  UCAM Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 29, 2020
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)