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

Fever Clinical Trial

Official title:

Evaluation of a m-Health System for Tracking Kangaroo Mother Care and Temperature for Providing Feedback to Family Care Givers or Front-line Workers to Enhance Kangaroo Mother Care Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929977
• Other study ID #: OPP1182699
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2021
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 49 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
India	St Johns Medical College and Hospital	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
St. John's Research Institute	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

India, 

References & Publications (11)

Baig MM, Gholamhosseini H, Connolly MJ. A comprehensive survey of wearable and wireless ECG monitoring systems for older adults. Med Biol Eng Comput. 2013 May;51(5):485-95. doi: 10.1007/s11517-012-1021-6. Epub 2013 Jan 19. Review. — View Citation

Bergh AM, Manu R, Davy K, van Rooyen E, Asare GQ, Williams JK, Dedzo M, Twumasi A, Nang-Beifubah A. Translating research findings into practice--the implementation of kangaroo mother care in Ghana. Implement Sci. 2012 Aug 13;7:75. — View Citation

Conde-Agudelo A, Díaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2014 Apr 22;(4):CD002771. doi: 10.1002/14651858.CD002771.pub3. Review. Update in: Cochrane Database Syst Rev. 2016;8:CD002771. — View Citation

Engmann C, Wall S, Darmstadt G, Valsangkar B, Claeson M; participants of the Istanbul KMC Acceleration Meeting. Consensus on kangaroo mother care acceleration. Lancet. 2013 Nov 30;382(9907):e26-7. doi: 10.1016/S0140-6736(13)62293-X. Epub 2013 Nov 16. — View Citation

Fink G, Ross R, Hill K. Institutional deliveries weakly associated with improved neonatal survival in developing countries: evidence from 192 Demographic and Health Surveys. Int J Epidemiol. 2015 Dec;44(6):1879-88. doi: 10.1093/ije/dyv115. Epub 2015 Jun 30. — View Citation

Lawn JE, Kinney MV, Belizan JM, Mason EM, McDougall L, Larson J, Lackritz E, Friberg IK, Howson CP; Born Too Soon Preterm Birth Action Group. Born too soon: accelerating actions for prevention and care of 15 million newborns born too soon. Reprod Health. 2013;10 Suppl 1:S6. doi: 10.1186/1742-4755-10-S1-S6. Epub 2013 Nov 15. Review. — View Citation

Lee YG, Jeong WS, Yoon G. Smartphone-based mobile health monitoring. Telemed J E Health. 2012 Oct;18(8):585-90. doi: 10.1089/tmj.2011.0245. — View Citation

Lund C. Medical adhesives in the NICU. Newborn and Infant Nursing Reviews 2014; 14; 14(4):160-165. DOI: 10.1053/j.nainr.2014.10.001

Mony PK, Jayanna K, Bhat S, Rao SV, Crockett M, Avery L, Ramesh BM, Moses S, Blanchard J. Availability of emergency neonatal care in eight districts of Karnataka state, southern India: a cross-sectional study. BMC Health Serv Res. 2015 Oct 6;15:461. doi: 10.1186/s12913-015-1126-3. — View Citation

Udani RH, Hinduja ARA, Rao SPN, Kabra NS. Role of Kangaroo Mother Care in Preventing Neonatal Morbidity in the Hospital and Community: A review article. Journal of Neonatology, Oct-Dec 2014; 28 (4):29-36.

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world	1. Number of hypothermia (less than 36.5 degree centigrade) episodes	5 months
Primary	Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world	1. No Kangaroo Mother Care ( Skin to skin contact between mother and baby) for 6 hours (alerted through RBM device)	5 months
Secondary	Development of entire computational hardware of the remote bio-monitoring device	No of alert messages from the RBM to project staffs.; No of heat map views - total and within 24 hrs.; No of responses to failure of normal temperature range (36.5-37 degree centigrade/ Kangaroo Mother Care alerts)	8 months

External Links

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