Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

Army Medical University of People's Liberation Army

Status: Withdrawn

Conditions: Whole-Body Hypothermia; Hypoxic- Ischemic Encephalopathy; Brain Injury

Treatments: Device: modified Whole-Body Hypothermia; Device: standard Whole-Body Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT05581927

Whole-Body Hypothermia

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

modified Whole-Body Hypothermia

Experimental group

Description:

patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure.

Treatment:

Device: modified Whole-Body Hypothermia

standard Whole-Body Hypothermia

Active Comparator group

Description:

patients were allocated to standard Whole-Body Hypothermia.

Treatment:

Device: standard Whole-Body Hypothermia