Preterm Clinical Trial
Official title:
Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh.
Verified date | February 2024 |
Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Hours to 72 Hours |
Eligibility | Inclusion Criteria: 1. Neonate aged between 0-72 hours 2. Birthweight between 1800g to 2000g 3. No gross congenital anomaly 4. Normal heart 100-160 per minute 5. Capillary Refill Time =3 sec 6. Respiratory rate 30-59 per minute 7. Breaths comfortably (no chest indrawing, No gasping) 8. No sign of respiratory distress (respiratory rate within normal limit) 9. Pink in room air (without oxygen therapy) 10. H/O No prolonged or frequent apnea & no visible apnea during study enrolment 11. No major surgical problem Exclusion Criteria: 1. In nasogastric tube 2. In oxygen therapy 3. In intravenous fluid |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bangabandhu Sheikh Mujib Medical University (BSMMU) | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Directorate General of Health Services (DGHS), Bangladesh, Poeticgem International Ltd, University of Dhaka |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. | Percentage of events maintained the body temperature in euthermic range among the enrolled preterm or low birthweight neonates. | 2 hours per event |
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