CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
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|ClinicalTrials.gov Identifier: NCT00383305|
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : October 3, 2006
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypoxic-Ischemic Encephalopathy (HIE)||Device: Cool-Cap||Not Applicable|
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+/-0.5 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 infant's scalp will cool the head. The core rectal temperature of the infant will be maintained at 34.5+/-0.5 degC by adjusting the cap water temperature. The infant's 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 0.5 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 Type :||Interventional (Clinical Trial)|
|Enrollment :||235 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain-Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy|
|Study Start Date :||July 1999|
|Study Completion Date :||September 2003|
- Combined death or severe neurodevelopmental disability in the first 18 months of life.
- Length of hospitalization during NICU course in those surviving to discharge and for whom support was not withdrawn.
- Multi-organ dysfunction (3 or more organ systems) in the neonatal period.
- Rate of multiple handicap in survivors (Multiple handicap will be defined as the presence of any two of the following in an infant: neuromotor disability (Level 3-5 on GMF classification), mental delay, epilepsy, cortical visual impairment, sensorineural
- Bayley PDI score
- Sensorineural hearing loss >= 40 dB
- Epilepsy: recurrent seizures beyond the neonatal period, requiring anticonvulsant therapy at the time of assessment.
- Microcephaly: head circumference < (mean - 2SD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383305
|Principal Investigator:||Peter D Gluckman, M.D.||The Liggins Institute, University of Auckland; Auckland, New Zealand|
|Principal Investigator:||John S. Wyatt, M.D.||University College London; London, UK|
|Study Director:||Alistair J Gunn, M.D., Ph.D.||Department of Physiology, University of Auckland; Auckland, New Zealand|