Clinical trial NCT05581927: Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)
Official title: Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoxic- Ischemic Encephalopathy
Whole-Body Hypothermia
Brain Injury
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
name: Children's Hospital of Suzhou
name: Women and Children's Hospital of Chongqing
name: Women and Children's Hospital of Guangxi
name: People's hospital of Guangyuan
First posted: 2022-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: death
timeFrame: 30 days
measure: brain injury
timeFrame: 30 days
Secondary outcomes:
measure: the incidence of suspend of Whole-Body Hypothermia
timeFrame: within 3 days
measure: the incidence of discharge according to the doctor's suggestion
timeFrame: 2-3 weeks
measure: the incidence of intraventricular hemorrhage
timeFrame: 2-3 week
measure: the incidence of periventricular leukomalacia
timeFrame: within 30 days
measure: neurodevelopmental assessment
timeFrame: one month
measure: neurodevelopmental assessment
timeFrame: 18-36 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: