Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383305
Status:
COMPLETED
Last Update Posted:
2006-10-03
First Post:
2006-09-29
Brief Title:
CoolCap Trial Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
Sponsor:
Olympic Medical
Organization:
Olympic Medical
Study Overview
Official Title:
Brain-Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
Status:
COMPLETED
Status Verified Date:
2006-09
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:
This is a research study of head cooling Its goal is to determine whether cooling babies heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain In this study half of the babies selected at random will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain The rest of the babys body will be maintained at a defined temperature by a standard overhead radiant heater The study protocol includes the taking and analysis of blood samples performance of brain wave tests imaging of the brain by ultrasound and other tests as clinically indicated Neurodevelopmental outcome will also be assessed at 18 months of age
Detailed Description:
The objective of this study is to determine whether head cooling with mild systemic hypothermia in term infants following perinatal asphyxia is a safe procedure that improves survival without neurodevelopmental disability Outcome will be assessed by survival and neurological and neurodevelopmental testing at 18 months of age
Within 6 hours of birth infants will be randomized to either a non-cooled control group with rectal temperature kept at 37-05 degC or to head cooling with mild systemic hypothermia as follows A cooling device capable of circulating cool water in a temperature-regulated manner through a cap fitted around the infants scalp will cool the head The core rectal temperature of the infant will be maintained at 345-05 degC by adjusting the cap water temperature The infants rectal nasopharyngeal scalp fontanel and skin abdominal temperatures will be continuously monitored Also metabolic cardiovascular pulmonary and coagulation laboratory measurements will be assessed at predefined time points Cooling will be maintained for 72 hours followed by four hours of rewarming with the goal of raising the rectal temperature to normal body temperature by 05 degC per hour The outcome measure of severe neurodevelopmental disability and survival rates at 18 months of age will be assessed by blinded independent observers
Within 6 hours of birth infants will be randomized to either a non-cooled control group with rectal temperature kept at 37-05 degC or to head cooling with mild systemic hypothermia as follows A cooling device capable of circulating cool water in a temperature-regulated manner through a cap fitted around the infants scalp will cool the head The core rectal temperature of the infant will be maintained at 345-05 degC by adjusting the cap water temperature The infants rectal nasopharyngeal scalp fontanel and skin abdominal temperatures will be continuously monitored Also metabolic cardiovascular pulmonary and coagulation laboratory measurements will be assessed at predefined time points Cooling will be maintained for 72 hours followed by four hours of rewarming with the goal of raising the rectal temperature to normal body temperature by 05 degC per hour The outcome measure of severe neurodevelopmental disability and survival rates at 18 months of age will be assessed by blinded independent observers
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HIE-0198 | None | None | None |
| PMA P040025 | None | None | None |