m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
Condition: Preterm Infant; Low Birth Weight Infant; Kangaroo Mother Care; Hypothermia, Newborn; Fever
MeSH terms: Hypothermia; Birth Weight
Study type: Interventional

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.
    

Detailed description: 
      Project design and implementation plan:

      The logic model envisioned in this study as i) wearable sensors, technology design and
      development with research team personnel as 'inputs'; ii) data analytics deployment with
      detection of abnormalities as 'processes'; and iii) feedback alerts appraisal as the
      'outputs' for this phase of testing.

      Experimental plan comprises of two steps: a non-clinical phase and a clinical phase.

      i) The non-clinical phase comprises of the design, development and deployment of the data
      capture and analytics system. This includes mobile phone app building with features such as
      push notifications, offline data storage and synchronization on connectivity, local data
      analysis (with sequentially increasing capabilities as more data comes in) and alerting
      stakeholders. In addition, capability development of primary nodes for temporary storage and
      real-time data analysis as also for long-term data storage capabilities that could be scaled
      to district-level and state-level expansion in future will be done. Data monitoring capacity
      will be built on real-time visualization dashboards and raising alerts for targeted
      stakeholders. The entire computational hardware, algorithms/AI engine, network architecture,
      overall data visualization including heat maps (infrastructure) for this proposed study will
      be developed by industry experts (will be subcontracted).

      ii)In the second phase, it is proposed to undertake a technological-feasibility study as a
      small-scale clinical trial (in a convenient sample of 20 mother-baby pairs) for testing in
      real-world conditions while the mother-infant pairs are in the hospital for a few days and
      when they are discharged for follow-up at home for up to a week. This phase will also include
      a qualitative research component to study acceptability and feasibility of alerting and
      actionable advisories sent to care-givers and field staff. All data obtained from this
      program will reside within dedicated servers with storage facilities within the selected
      hospital from where mother-infant pairs are recruited. Institutional Ethics Committee
      approval, clinical trial registration and data safety monitoring board constitution will be
      undertaken to protect human research participants.
    

Intervention name(s): Wearable device with smart mobile phone
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: Wearable device combined with a smart mobile phone and back-end analytics system that acts as a temperature and touch sensor and actuator will be evaluated.
Masking: None (Open Label)
Primary purpose: Device Feasibility