Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540222
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Sustained Cord Circulation at Emergency Cesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
Status:
NOT_YET_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:
SUCCECS
Brief Summary:
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section The main question it aims to answer is Does sustained cord circulation reduce admission rates to neonatal care
Researchers will compare resuscitation with sustained cord circulation to standard resuscitation practices to see if it provides better outcomes
Participants term neonates born by emergency Cesarean section will
Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes
Researchers will compare resuscitation with sustained cord circulation to standard resuscitation practices to see if it provides better outcomes
Participants term neonates born by emergency Cesarean section will
Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes
Detailed Description:
Study Title
Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section A Multicenter Randomized Controlled Trial
Primary Objectives
To compare sustained cord circulation during resuscitation with standard care for term neonates born by emergency Cesarean section and evaluate
A composite outcome of admission to neonatal care for predefined criteria asphyxia at birth respiratory distress hypoxic-ischemic encephalopathy hypoglycemia and death before admission
Secondary Objectives Secondary outcomes will include short and long-term neonatal outcomes adverse maternal and neonatal outcomes and caregivers and staffs experiences
Study Design A multicenter stepped-wedge cluster randomized trial
Study Population Singleton term neonates born alive gestational age 37 weeks by emergency Cesarean section with epiduralspinal anesthesia where the pediatricneonatal team has been called to attend
Intervention Neonates will be kept close to the mother with the cord intact When in need of ventilatory support the neonatal team will give respiratory support with sustained cord circulation following neonatal cardiopulmonary resuscitation CPR guidelines Cord clamping will be performed after respiration has been established and at the earliest after three minutes
Control Management according to standard care including immediate cord clamping for neonates requiring ventilatory support In cases where ventilatory assistance is not necessary cord clamping will be performed within 60 seconds of birth adhering to established clinical guidelines for neonatal management
Power analysis With significance level 005 the power to detect the anticipated risk reduction 50 would be 085
Study Duration 2025-2028
Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section A Multicenter Randomized Controlled Trial
Primary Objectives
To compare sustained cord circulation during resuscitation with standard care for term neonates born by emergency Cesarean section and evaluate
A composite outcome of admission to neonatal care for predefined criteria asphyxia at birth respiratory distress hypoxic-ischemic encephalopathy hypoglycemia and death before admission
Secondary Objectives Secondary outcomes will include short and long-term neonatal outcomes adverse maternal and neonatal outcomes and caregivers and staffs experiences
Study Design A multicenter stepped-wedge cluster randomized trial
Study Population Singleton term neonates born alive gestational age 37 weeks by emergency Cesarean section with epiduralspinal anesthesia where the pediatricneonatal team has been called to attend
Intervention Neonates will be kept close to the mother with the cord intact When in need of ventilatory support the neonatal team will give respiratory support with sustained cord circulation following neonatal cardiopulmonary resuscitation CPR guidelines Cord clamping will be performed after respiration has been established and at the earliest after three minutes
Control Management according to standard care including immediate cord clamping for neonates requiring ventilatory support In cases where ventilatory assistance is not necessary cord clamping will be performed within 60 seconds of birth adhering to established clinical guidelines for neonatal management
Power analysis With significance level 005 the power to detect the anticipated risk reduction 50 would be 085
Study Duration 2025-2028
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