Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06277843
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Development and Testing of a Low-cost and Reusable Thermal Jacket for Managing Preterm or Low-birth-weight Neonates in Bangladesh
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hoursday 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 icddrb 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
Maintaining continuous KMC for at least 16-20 hoursday 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 icddrb 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 365C-375C 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 neonates body temperature drops below 365C or rises above 375C 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 studys responsibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None