Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 325
- Locations
- 2
- Primary Endpoint
- Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors
Study Overview
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 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 6 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors
Time Frame: 18 months
Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean \[± standard deviation (SD)\] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.
Secondary Outcomes
- Mortality(18 months)
- Culture Proven Sepsis(Duration of hospital stay, on average 22 days)
- Major Venous Thrombosis(Duration of hospital stay, on average 22 days)
- Sensorineural Hearing Loss(18 months)
- Persistent Hypotension(Duration of hospital stay, on average 22 days)
- Intracranial Haemorrhage(Duration of hospital stay, on average 22 days)
- Pulmonary Hypertension(Duration of hospital stay, on average 22 days)
- Prolonged Blood Coagulation Time(Duration of hospital stay, on average 22 days)
- Necrotising Enterocolitis(Duration of hospital stay, on average 22 days)
- Cardiac Arrhythmia(Duration of hospital stay, on average 22 days)
- Thrombocytopenia(Duration of hospital stay, on average 22 days)
- Pulmonary Haemorrhage(Duration of hospital stay, on average 22 days)
- Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)(18 months)
- Microcephaly(18 months)
- Renal Failure Treated With Dialysis(Duration of hospital stay, on average 22 days)
- Severe Neurodevelopmental Disability(18 months)
- Pneumonia(Before discharge from hospital)
- Pulmonary Airleak(Duration of hospital stay, on average 22 days)
- Duration of Hospitalisation(Duration of hospital stay, on average 22 days)
- Multiple Handicap(18 months)
- Bayley Psychomotor Developmental Index Score (PDI)(18 months)