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

St. John's Research Institute

Status: Completed

Conditions: Fever; Preterm Infant; Hypothermia, Newborn; Low Birth Weight Infant; Kangaroo Mother Care

Treatments: Device: Wearable device with smart mobile phone

Study type: Interventional

Funder types: Other

Identifiers

NCT04929977

OPP1182699

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 2 days to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stable LBW babies who are less than 2000 grams
• Kangaroo care provider who could preferably be the mother or any other family member

Exclusion criteria

• Extreme preterm infants (corrected gestational age less than 28 weeks)
• Any family member who is unwilling to hold the infant in Kangaroo Mother Care position with the wearable device or if presenting with any infection

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Wearable device with smart mobile phone

Other group

Description:

20 mother/care provider-infant pairs practicing Kangaroo Mother Care, from a tertiary super-specialty hospital selected to wear the device ( few days in the hospital and for a week at home when discharged)

Treatment:

Device: Wearable device with smart mobile phone