Brain Injury, Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia
Conditions
Brief summary
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.
Detailed description
Reductions in brain temperature by 2°C to 5°C provide neuroprotection in newborn and adult animal models of brain ischemia.Brain cooling has a favorable effect on multiple pathways contributing to brain injury, including excitatory amino acids, the cerebral energy state, cerebral blood flow and metabolism, nitric oxide production, and apoptosis. Brain cooling is effective in reducing the extent of brain injury even when it is initiated up to 5.5 hours after brain ischemia in near-term sheep fetuses.But, epidemiological data showed that, in non-developed countries and areas,Whole-body hypothermia is related to the increased mortality and brain injury. The cause is unclear.
Interventions
DEVICEmodified Whole-Body Hypothermia
patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure
DEVICEstandard Whole-Body Hypothermia
patients were allocated to standard Whole-Body Hypothermia
Sponsors
Children's Hospital of Chongqing Medical University
Children's Hospital of Suzhou
Women and Children's Hospital of Chongqing
Women and Children's Hospital of Guangxi
People's hospital of Guangyuan
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
Eligibility
Sex/Gender
ALL
Age
0 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
* pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical cord blood or any blood during the first hour after birth. If, during this interval,a pH was between 7.01 and 7.15, a base deficit was between 10 and 15.9 mmol per liter. or a blood gas was not available, additional criteria were required. These included an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture,uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes. * equal to or more than 36 weeks
Exclusion criteria
* congenital malformation * parents' refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | 30 days | neonates are dead during hospital |
| brain injury | 30 days | neonates are diagnosed with brain injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of intraventricular hemorrhage | 2-3 week | intraventricular hemorrhage was diagnosed |
| the incidence of suspend of Whole-Body Hypothermia | within 3 days | Whole-Body Hypothermia is suspended |
| neurodevelopmental assessment | one month | neurodevelopment is assessed using NBNA |
| the incidence of periventricular leukomalacia | within 30 days | Periventricular leukomalacia is diagnosed |
| the incidence of discharge according to the doctor's suggestion | 2-3 weeks | neonates were discharged according to the doctor's suggestion |
Countries
China
Outcome results
None listed