Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147030
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2005-09-05
Brief Title:
TOBY TOtal Body hYpothermia a Study of Treatment for Perinatal Asphyxia
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
Status:
COMPLETED
Status Verified Date:
2013-11
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:
Hypothesis Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability
This study aims to determine whether whole body cooling to 33-34C is a safe treatment that improves survival without severe neurological or neurodevelopmental impairments at 18 months of term infants suffering perinatal asphyxial encephalopathy
This study aims to determine whether whole body cooling to 33-34C is a safe treatment that improves survival without severe neurological or neurodevelopmental impairments at 18 months of term infants suffering perinatal asphyxial encephalopathy
Detailed Description:
This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4C following perinatal asphyxia improves survival without neurodevelopmental disability
Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 02C or to whole body cooling with the rectal temperature kept at 335 05C for 72 hours followed by slow rewarming
The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing
Eligibility criteria
Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia a combination of clinical and EEG criteria
Exclusion criteria
Infants expected to be 6 hours of age at the time of randomisation or infants with major congenital abnormalities
Intervention
Intensive care with whole body cooling versus intensive care without whole body cooling babies are cooled to 335C for 72 hours
Main Outcomes
Death and severe neurodevelopmental impairment at 18 months of age
Secondary Outcomes
Cerebral thrombosis or haemorrhage persistent hypotension pulmonary hypertension abnormal coagulation arrhythmia and sepsis in the neonatal period Neurological impairments at 18 months
Number of patients required 236
On 30th November 2006 when recruitment closed 325 babies had been recruited
Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 02C or to whole body cooling with the rectal temperature kept at 335 05C for 72 hours followed by slow rewarming
The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing
Eligibility criteria
Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia a combination of clinical and EEG criteria
Exclusion criteria
Infants expected to be 6 hours of age at the time of randomisation or infants with major congenital abnormalities
Intervention
Intensive care with whole body cooling versus intensive care without whole body cooling babies are cooled to 335C for 72 hours
Main Outcomes
Death and severe neurodevelopmental impairment at 18 months of age
Secondary Outcomes
Cerebral thrombosis or haemorrhage persistent hypotension pulmonary hypertension abnormal coagulation arrhythmia and sepsis in the neonatal period Neurological impairments at 18 months
Number of patients required 236
On 30th November 2006 when recruitment closed 325 babies had been recruited
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