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

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Objective

To study the effectiveness of a hypothermia monitoring device in reducing neonatal mortality and increasing Kangaroo Mother Care (KMC) compliance.

Design

Non-randomized controlled trial.

Setting

Three government Sick Newborn Care Units and seven Primary Health Centers in Udaipur and Dungarpur districts of Rajasthan for four months. The follow-up period was four weeks for each baby.

Participants

386 neonates were included in the study. 250 (64.76%) newborns 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 four weekly follow-ups were eligible for participation. Infants with complications or those leaving against medical advice were not eligible.

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 four-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.


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