Clinical safety trial of a thermal jacket among preterm or low birthweight neonates for hypothermia management at a tertiary-level health facility in Bangladesh.

Background: Hypothermia is a common and critical issue for preterm and low birthweight (LBW) neonates, who require effective thermal care management to survive. In a safety trial, we tested a thermal jacket comprising a reusable chemical warming pad and an insulating jacket designed for hypothermia management when skin-to-skin contact is not possible. We assessed its performance in maintaining neonates' body temperature within the euthermic range (36.5°C to 37.5°C) and evaluated whether it caused any adverse effects. Methods: We conducted a single-arm, open-label safety trial at a tertiary-level hospital in Bangladesh. We analysed a total of 68 two-hour thermal jacket events involving nine preterm or LBW neonates. The primary outcome was the percentage of events in which the neonate's body temperature was maintained within the euthermic range for two hours. The secondary outcome was any incidence of adverse clinical signs, including burn, rash, or skin irritation, that we observed during the event. We monitored axillary temperature and other vital signs at the beginning and every 30 minutes throughout each event period. We used a generalised estimating equations-Firth model to assess the effects of study factors on trial outcomes and success status. Results: The thermal jacket successfully maintained the euthermic temperature range in 96% of events. Its performance remained consistent across varying ambient temperature and humidity conditions, with no significant influence from environmental factors. The three unsuccessful events recorded temperatures outside the euthermic range, with a minimum temperature of 36.3°C and a maximum of 37.8°C. Neonates with initial hypothermia reached euthermia faster and remained euthermic with the support of the thermal jacket. We observed no instances of the above clinical signs. Conclusions: The thermal jacket safely maintained the preterm or LBW neonate's body temperature within the euthermic range. Further research is needed to assess the efficacy and effectiveness of this approach in larger clinical settings. Registration: ClinicalTrials.gov: NCT06277843.