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| Sponsor: | Imperial College London |
|---|---|
| Collaborator: |
Medical Research Council |
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00147030 |
Purpose
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 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.
| Condition | Intervention |
|---|---|
|
Asphyxia Neonatorum Hypoxia Encephalopathy Seizures |
Procedure: Whole body mild induced hypothermia |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy |
| Enrollment: | 325 |
| Study Start Date: | December 2002 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Procedure: Whole body mild induced hypothermia
Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia
|
| 2: No Intervention |
This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4°C 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 ± 0.2°C or to whole body cooling with the rectal temperature kept at 33.5 ± 0.5°C 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 33.5°C 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.
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
The infant will be assessed sequentially by criteria A, B and C listed below:
A. Infants =>36 completed weeks gestation admitted to the NICU with at least one of the following:
Infants that meet criteria A will be assessed for whether they meet the neurological abnormality entry criteria (B) by trained personnel:
B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
Infants that meet criteria A & B will be assessed by aEEG (read by trained personnel):
C. At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
Exclusion criteria
Contacts and Locations| United Kingdom | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Principal Investigator: | Denis Azzopardi, MD; FRCPCH | Imperial College London |
More Information
| Study ID Numbers: | ISRCTN89547571 |
| Study First Received: | September 5, 2005 |
| Last Updated: | April 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00147030 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Hypoxia Ischaemia Encephalopathy Neonatal |
Hypothermia Perinatal Cooling Whole/Total Body |
|
Asphyxia Neonatorum Liver Diseases Death Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Central Nervous System Viral Diseases Brain Diseases Signs and Symptoms Pathologic Processes Mental Disorders Signs and Symptoms, Respiratory Infant, Newborn, Diseases Neurobehavioral Manifestations Hepatic Insufficiency |
Delirium Liver Failure Metabolic Diseases Nervous System Diseases Poisoning Wounds and Injuries Central Nervous System Diseases Confusion Encephalitis Anoxia Virus Diseases Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections |
