Abstract
Objective
To study the effectiveness of a hypothermia monitoring device in reducing neonatal mortality and increasing Kangaroo Mother Care compliance.
Design
Non-randomized controlled trial.
Setting
3 government Sick Newborn Care Units and 7 Primary Health Centers in Udaipur and Dungarpur districts of Rajasthan for 4 months. The follow-up period was 4 weeks for each baby.
Participants
Total 386 neonates were included in the study. 250 (64.76%) new-borns in the study group (BEMPU bracelet) and 136 (35.23%) enrolled in the control group. Clinically stable babies discharged below 2500 grams, whose parents could be reached by phone, and who could visit the facility for 4 weekly follow-ups were eligible for participation. Infants with complications or those leaving against medical advice were not eligible.
Intervention
The BEMPU Bracelet is a medical device that provides 4 weeks of continuous hypothermia monitoring for new-borns, and emits an audio-visual alarm when the temperature of the newborn is below 36.5°C.
Outcome
Neonatal mortality over the 4-week period.
Results
Mortality data was obtained for 92% (229 babies) of the study group and 91 % of the control group (124 babies) at the end of the 4-week period. The intervention group had a significantly lower mortality rate as compared to the control group (6% vs. 14%, P=0.013). Weight data from 51% of the study group (128 babies) and 32% of the control group (44 babies) did not show a significant difference in weight gain between the groups.
Conclusion
The observed effect on mortality and qualitative feedback on KMC compliance suggest the utility of the device in the community settings.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
The United Nations Children′s Fund. Low Birth weight: Country, Regional and Global Estimates, 2019. Available from: https://www.unicef.org/publications/index_24840.html. Accessed August 20, 2019.
India: Profile of preterm and low birth weight prevention and care. Available from: https://www.healthynewbornnetwork.org/hnncontent/uploads/India-1.pdf/ Accessed August 20, 2019.
Lunze K, Bloom D, Jamison D, Hamer, D. The global burden of neonatal hypothermia: Systematic review of a major challenge for newborn survival. BMC Medicine. 2013;11:24.
Lunze K, Hamer D. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012;32: 317–24.
Chan G, Labar A, Wall S, Atun R. Kangaroo mother care: a systematic review of barriers and enablers. Bull World Health Organ. 2015;94:130–411
The National Family Health Survey 2015-16. State fact Sheet Rajasthan. Available from: http://rchiips.org/NFHS/pdf/NFHS4/RJ_FactSheet.pdf.s Accessed August 20, 2019.
National Family Health Survey, 2019. Available from: http://rchiips.orgs/nfhs/njhs4.shtml. Accessed August 20, 2019.
Tanigasalam V, Vishnu Bhat B, Adhisivam B, Balachander B, Kumar H. Hypothermia detection in low birth weight neonates using a novel bracelet device. J Matern Fetal Neonatal Med. 2019;32:2653–6.
Census of India Website: SRS Statistical Report 2015. Available from: http://www.censusindia.gov.in/vital_statis-tics/SRS_Reports_2015.html. Accessed August 20, 2019.
Census of India: Annual Health Survey 2011 - 12 Fact Sheet. Available from: http://www.censusindia.gov.in/vital_statistics/AHSBulletins/AHS_Factsheets_201112. html Accessed August 20, 2019.
Rehana S, Tarab M, Dania M, Zohra L, Das J, Bhutta Z. Essential childbirth and postnatal interventions for improved maternal and neonatal health. Reproductive health. 2014;11:S3.
Kumar V, Mohanty S, Kumar A, Misra R, Santosham M, Awasthi S, et al. Effect of community-based behaviour change management on neonatal mortality in Shivgarh, Uttar Pradesh, India: A cluster-randomised controlled trial. Lancet. 2008;372:1151–62.
Acknowledgements
Mission Director of National Health Mission Rajasthan and the Chief Medical and Health Officer in Udaipur for their encouragement and guidance. Annika Gage, Abby Smith, and Kembo Matungulu for their work in revising the manuscript for intellectual content.
Funding
Funding: The cost of the BEMPU bracelets involved in the study were supplied to the NHM Rajasthan using the grants of Grand Challenges Canada via BEMPU Health. For the study, the BEMPU Bracelets were provided free of cost by BEMPU Health, and the data entry operators responsible for entering all collected data were compensated by BEMPU Health.
Author information
Authors and Affiliations
Contributions
Contributors: MS: conception and design of the study, VM: data analysis, drafting manuscript, MS: conception and design of study; DS: acquisition of data; RDB: implementation of the study, AS: data analysis. All authors approved the final version of manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Corresponding author
Ethics declarations
Competing interests: All data collection was overseen by the National Health Mission Rajasthan and the WISH Foundation. Data analysis and the authorship of this publication were shared between BEMPU Health and the WISH Foundation. BEMPU Health team conducted the training required for the bracelet use. Staff of the NICUs of the hospitals in the studies carried out the study.
Rights and permissions
About this article
Cite this article
Sharma, M., Morgan, V., Siddadiah, M. et al. Impact of a Novel Hypothermia Alert Device on Death of Low Birthweight Babies at Four Weeks: A Non-randomized Controlled Community-based Trial. Indian Pediatr 57, 305–309 (2020). https://doi.org/10.1007/s13312-020-1780-3
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13312-020-1780-3