Impact of a Novel Hypothermia Alert Device on Death of Low Birthweight Babies at Four Weeks: A Non-randomized Controlled Community-based Trial

Abstract

To study the effectiveness of a hypothermia monitoring device in reducing neonatal mortality and increasing Kangaroo Mother Care compliance. Non-randomized controlled trial. 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. 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. 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. Neonatal mortality over the 4-week period. 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. The observed effect on mortality and qualitative feedback on KMC compliance suggest the utility of the device in the community settings.