Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532266
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Randomised Controlled Trial on Using Active Warming to Prevent Newborn Hypothermia After Caesarean Delivery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Controlled Trial Using Active Warming in Prevention of Newborn Hypothermia After Caesarean Delivery Without Interruption to Skin-to-skin Contact
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite the enormous advantages that skin-to-skin contact STSC and Delaying Cord Clamping DCC bring newborns can lose heat quickly if they are not thermally protected In the first 10-20 minutes after birth newborns can experience a body temperature drop of between 2C to 4C if they are not properly dried and covered In 2014 Horn et al published a research paper regarding the incidence and prevention of newborn hypothermia after Caesarean delivery The findings showed up to 80 of newborns become hypothermic if only warm towels passive insulation were used during STSC after Caesarean delivery Evidence also shows higher hypothermia rates in infants born by Caesarean section than vaginal birth
STSC will begin while Caesarean section continues Newborns will be clothed in a cotton hat and diaper Newborns will be placed on bare chest of mother horizontally in prone position The head of the newborn will turn laterally making the nose and mouth unobstructed Newborns hands are not swaddled and are free to move to allow exploration to facilitate first feeding In both groups infants will be covered from head-to-toe with 3 layers of 100 cotton woven blankets taken from a 70C heating cabinet For the intervention group thermal blanket will be placed on top of the cotton blanket Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top The thermal blanket will be placed inside a pillowcase like cotton blanket to avoid direct contact with mother or newborn
STSC will begin while Caesarean section continues Newborns will be clothed in a cotton hat and diaper Newborns will be placed on bare chest of mother horizontally in prone position The head of the newborn will turn laterally making the nose and mouth unobstructed Newborns hands are not swaddled and are free to move to allow exploration to facilitate first feeding In both groups infants will be covered from head-to-toe with 3 layers of 100 cotton woven blankets taken from a 70C heating cabinet For the intervention group thermal blanket will be placed on top of the cotton blanket Newborn will be first covered with conventional warm blanket then adding the thermal blanket on top The thermal blanket will be placed inside a pillowcase like cotton blanket to avoid direct contact with mother or newborn
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None