NCT06277843

Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.

Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh · Academic / Other
• Sex: All
• Age: 0 Hours – 72 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

We will equip a single arm trial with no control group design, in which every enrolled neonate will get the experimental therapy (thermal jacket) for this phase. A thermal jacket trial on a preterm or LBW neonate will be considered an event. An event will be considered a success if the neonate can maintain the body temperature in the euthermic range (36.5°C-37.5°C) using the thermal jacket for two hours. Thus, the failure event will be if the thermal jacket fails to maintain euthermia for neonates for two hours. Suppose, the neonate's body temperature drops below 36.5°C or rises above 37.5°C, the neonate will be monitored for maximum 5 minutes. If not recovered from the state, the neonate then immediately will be removed from the event for the appropriate management under the study's responsibility.

Conditions

• Preterm
• Low Birthweight
• Hypothermia Neonatal

Interventions

Type	Name	Description
DEVICE	Thermal Jacket	In the intervention group, the enrolled preterm or low birthweight eligible neonates gets the intervention (Thermal Jacket) as a supplement of Kangaroo Mother Care (KMC).

Timeline

• Start date: 2022-06-13
• Primary completion: 2022-09-01
• Completion: 2022-09-30
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: Bangladesh