The TempWatch’s impact has been studied in multiple hospitals and community settings in government and private centers among rural, tribal, and urban populations.

Accurate in catching hypothermia

A study conducted in the step-down nursery of the newborn unit of JIPMER Pondicherry, a tertiary level hospital, found that the TempWatch is an accurate screening tool to detect and alert for neonatal hypothermia with 99% sensitivity and 95% specificity.

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Prevalence of hypothermia in normal weight babies

Neonatal hypothermia poses a particular challenge for low birth weight (LBW) and preterm newborns, who struggle to regulate their own body temperatures. However, it is generally not considered a major issue in full-term and normal weight infants. This study conducted in a in a well managed tertiary care centre in Karnataka found high prevalence of hypothermia in healthy full-term infants.

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Evaluation by Centres for Disease

Control and Prevention (CDC), Atlanta

CDC conducted an evaluation of TempWatch implementation in Papua New Guinea to understand the feasibility and utility in detecting hypothermia. They found that the TempWatch is accurate, babies using the TempWatch received more kangaroo care, and TempWatch usage has improved the knowledge and attitude of parents taking care of their infants.

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BEMPU TempWatch has 10 publications, 2 UNICEF implementation reports, 1 US CDC evaluation and 1 cost-effectiveness documentation from Duke. There are also 4 studies ongoing.

Summary of key findings on TempWatch:

Accurate & Robust

  • Accuracy - A 2500 reading study found the device to have a 99% sensitivity, 95% specificity, 83% positive predictive value, and 99.6% negative predictive value (2)

  • Identifying a High Incidence of Hypothermia - JIPMER Pondicherry found the TempWatch detected hypothermia in 65% of 418 babies < 2kgs within the first 24 of birth. Another study at KLE Belgaum found the TempWatch detected hypothermia in 96% of term babies within the first 6 hours of transitory care.

Acceptable to Diverse Users

  • With Health Care Workers - 100% of 43 community health workers (ASHAs) in a Maharashtra study found the device useful . The US CDC reported signifiant aspects of feedback and observations from village health care workers implementing the TempWatch.

  • With Mothers - 100% of 43 mothers in a Hyderabad study found the TempWatch useful in detecting low temperature.

Drives Behaviour Change

  • Kangaroo Care - The US CDC found mothers in Papua New Guinea did significantly more instances of Kangaroo Care with the TempWatch than those without . A Bangalore RCT found mothers using the Tempwatch did 3 hours of kangaroo care vs 2 hours for those without during the first week .

  • Knowledge, Attitude, Practice - The US CDC found "knowledge, attitude and practices concerning the prevention and management of hypothermia among the non device users were found to be relatively lower or less accurate than the users".

Improved Clinical Outcomes

  • Increased weight gain - The US CDC found babies wearing the TempWatch gained more weight vs the controls . A Bangalore RCT found babies using the Tempwatch gained 28 grams per day vs 23 in the control over 4 weeks. A Delhi RCT found babies had statistically significant weight gain during their hospital stay. A Hyderebad RCT did not find a difference in weight gain between the two groups.

  • Decreased excessive weight loss - A Goa study with 515 babies found a significant reduction in excessive weight loss for newborns wearing the TempWatch vs control.

  • Potential for Decreased Mortality - A nonrandomized controlled trial in Rajasthan government hospitals with 386 newborns found a 4 week post-discharge mortality rate of 6% vs 14% in the BEMPU vs control group.

Additional Non Clinical or Peer Reviewed Evaluations

  • Implementation Information - Additional implementation experience can be observed in the extensive US CDC report for UNICEF Papua New Guinea, the deployment report from UNICEF Benin and the pilot evaluation report from UNICEF Pakistan.

  • Cost Effectiveness - A Duke University analysis found the TempWatch to be very cost-effective with a cost per live saved near $746 and cost per life-year extended at $25. Since the price of the product has decreased and a reusable device is launched, the estimated cost has significantly come down.

  • Ongoing Studies - We have studies ongoing at Monash University, Phillipines (KMC Foundation), Bangladesh and Ghana.

List of Publications  

  1. Tanigasalam et al., 2019. Hypothermia detection in low birth weight neonates using a novel bracelet device. Available at; https://www.ncbi.nlm.nih.gov/pubmed/29463144  

  2. Tanigasalam et al., 2019. Prevalence of Hypothermia among Low Birth Weight Neonates in a Tertiary Care Center in India. Available at; https://www.gkpublication.in/IJSHR_Vol.4_Issue.4_Oct2019/IJSHR0027.pdf  

  3. Role of Hypothermia Detecting Device during Transitional Adaptation of Healthy Full Term Infant http://www.ijnmr.net/articles/PDF/2284/45815_CE[Ra]_F(Sh)_PF1(AKA_KM)_PFA(SHU_AKA)_PN(SHU).pdf

  4. Jagdish et al., 2019. A randomized control trial of hypothermia alert device in low birth weight newborns and the effect on kangaroo mother care and weight gain. Available at;  https://www.ijpediatrics.com/index.php/ijcp/article/view/1205

  5. Sharma et al., 2020. Impact of a Novel Hypothermia Alert Device on Death of Low Birthweight Babies at Four Weeks: A Non-randomized Controlled Community-based Trial. Available at; https://www.ncbi.nlm.nih.gov/pubmed/32038035

  6. Sreekumar et al., 2019. Preventing excessive postnatal weight loss in healthy newborns. Will continuous temperature monitoring help? Available at; https://www.ijmbs.info/index.php/ijmbs/article/view/714

  7. Reddy et al., 2019. Neonatal Hypothermia Monitoring and Alerting Device, Acceptability among Mothers and Caregivers. Available at; https://www.ijrrjournal.com/IJRR_Vol.6_Issue.12_Dec2019/IJRR0030.pdf

  8. Reddy et al., 2020. TempWatch for Monitoring Hypothermia in Very-Low-Birth-Weight Infants: A Randomized Controlled Trial. Available at; https://www.perinatology.in/tempwatch-for-monitoring-hypothermia-in-verylowbirthweight-infants-a-randomized-controlled-trial 

  9. Mukane et al., Usability and acceptability of a hypothermia monitoring device in a community setting. Available at International Journal of Community Medicine and Public Health https://www.ijcmph.com/index.php/ijcmph/article/view/6226

  10. US CDC & UNICEF, PNG Evaluation Report https://www.unicef.org/evaldatabase/files/Final_Kol_Kilok_Evaluation_Report_PNG.pdf

  11. Mohammad Azad , Surender Singh Bisht , Amita Tyagi & M. L. Jaipal (2020): The role of a neonatal hypothermia alert device in promoting weight gain in LBW infants, The Journal of Maternal-Fetal & Neonatal Medicine, DOI: 10.1080/14767058.2020.1814244