Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Hours to 24 Hours (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
death
Time Frame: 30 days
neonates are dead during hospital
brain injury
Time Frame: 30 days
neonates are diagnosed with brain injury
Secondary Outcomes
- the incidence of periventricular leukomalacia(within 30 days)
- neurodevelopmental assessment(18-36 months)
- the incidence of suspend of Whole-Body Hypothermia(within 3 days)
- the incidence of discharge according to the doctor's suggestion(2-3 weeks)
- the incidence of intraventricular hemorrhage(2-3 week)
Investigators
Chen Long,MD
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University