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

NCT04929977 | Completed DMC

• 1 other identifier: OPP1182699
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Development of entire computational hardware of the remote bio-monitoring device

  8 months

Study Arms (1)

Wearable device with smart mobile phone

OTHER

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)

Device: Wearable device with smart mobile phone

Interventions

Wearable device with smart mobile phone DEVICE

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.

Wearable device with smart mobile phone

Eligibility Criteria

• Age: 2 Days - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. John's Research Institute: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

St Johns Medical College and Hospital

Bangalore, Karnataka, 560034, India

Location

Related Publications (11)

• Conde-Agudelo A, Diaz-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.

  PMID: 24752403 BACKGROUND

• 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.

  PMID: 23334714 BACKGROUND

• 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. doi: 10.1186/1748-5908-7-75.

  PMID: 22889113 BACKGROUND

• 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. No abstract available.

  PMID: 24246562 BACKGROUND

• 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.

  PMID: 26130739 BACKGROUND

• 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(Suppl 1):S6. doi: 10.1186/1742-4755-10-S1-S6. Epub 2013 Nov 15.

  PMID: 24625252 BACKGROUND

• 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.

  PMID: 23061640 BACKGROUND

• 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.

  PMID: 26444272 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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

MeSH Terms

Conditions

Premature Birth; Hypothermia; Fever

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Prem K Mony, MD; MSc-Epi

  St. John's Research Institute, Bangalore 560034

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: June 18, 2021
• Study Start: August 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)