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m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India

NCT04929977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-01

No results posted yet for this study

Summary

The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care adherence and temperature of neonate on a 24/7 basis and temperature of mother during these episodes), make intelligent and early diagnosis of (persistent or impending) neonatal hypothermia, maternal/neonatal fever and non-adherence to Kangaroo Mother Care and then trigger audio or visual alerts (via the wearable or smart-mobile phone) for action by the care-giver or front-line healthcare worker to enhance Kangaroo Mother Care duration or referral to a health facility as needed.

Conditions

  • Preterm Infant
  • Low Birth Weight Infant
  • Kangaroo Mother Care
  • Hypothermia, Newborn
  • Fever

Interventions

DEVICE

Wearable device with smart mobile phone

The wearable device will act as a sensor designed to identify critical parameters such as Kangaroo Mother Care adherence and temperature of the infant 24/7 and of the mother-infant pairs during these sessions.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • St. John's Research Institute

    lead OTHER

Principal Investigators

  • Prem K Mony, MD; MSc-Epi · St. John's Research Institute, Bangalore 560034

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Days
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-03-31
Completion
2019-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT04929977 on ClinicalTrials.gov