4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Preterm Infant Low Birth Weight Infant Kangaroo Mother Care Hypothermia, Newborn Fever Device: Wearable device with smart mobile phone Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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
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
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
Wearable device with smart mobile phone
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
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.
Outcome Measures
Primary Outcome Measures :
  1. Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. Number of hypothermia (less than 36.5 degree centigrade) episodes

  2. Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. No Kangaroo Mother Care ( Skin to skin contact between mother and baby) for 6 hours (alerted through RBM device)


Secondary Outcome Measures :
  1. Development of entire computational hardware of the remote bio-monitoring device [ Time Frame: 8 months ]
    1. No of alert messages from the RBM to project staffs.
    2. No of heat map views - total and within 24 hrs.
    3. No of responses to failure of normal temperature range (36.5-37 degree centigrade/ Kangaroo Mother Care alerts)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
India
St Johns Medical College and Hospital
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
St. John's Research Institute
Bill and Melinda Gates Foundation
Investigators
Layout table for investigator information
Principal Investigator: Prem K Mony, MD; MSc-Epi St. John's Research Institute, Bangalore 560034
Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date July 1, 2021
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2021)
  • Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. Number of hypothermia (less than 36.5 degree centigrade) episodes
  • Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. No Kangaroo Mother Care ( Skin to skin contact between mother and baby) for 6 hours (alerted through RBM device)
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. Number of hypothermia (less than 36.5 degree centigrade) episodes
  • Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world [ Time Frame: 5 months ]
    1. No KMC for 6 hours (alerted through RBM device)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2021) 		Development of entire computational hardware of the remote bio-monitoring device [ Time Frame: 8 months ]
  1. No of alert messages from the RBM to project staffs.
  2. No of heat map views - total and within 24 hrs.
  3. No of responses to failure of normal temperature range (36.5-37 degree centigrade/ Kangaroo Mother Care alerts)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021) 		Development of entire computational hardware of the remote bio-monitoring device [ Time Frame: 8 months ]
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 made available (subcontracted)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Preterm Infant
  • Low Birth Weight Infant
  • Kangaroo Mother Care
  • Hypothermia, Newborn
  • Fever
Intervention  ICMJE 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.
Study Arms  ICMJE Wearable device with smart mobile phone
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)
Intervention: Device: Wearable device with smart mobile phone
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2021) 		20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04929977
Other Study ID Numbers  ICMJE OPP1182699
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party St. John's Research Institute
Study Sponsor  ICMJE St. John's Research Institute
Collaborators  ICMJE Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: Prem K Mony, MD; MSc-Epi St. John's Research Institute, Bangalore 560034
PRS Account St. John's Research Institute
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP