Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.
NCT ID: NCT06277843 Phase: EARLY_PHASE1 Status: COMPLETED Enrollment: 10 Completion: 2022-09-30
Conditions
Preterm, Low Birthweight, Hypothermia Neonatal
Interventions
Thermal Jacket
Summary
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.
Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.
The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.
Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.
Primary Outcome
Body temperature of preterm or low birthweight neonates and duration of time in euthermic range.