NCT05581927

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

Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 0 Hours – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxic- Ischemic Encephalopathy
• Whole-Body Hypothermia
• Brain Injury

Interventions

Type	Name	Description
DEVICE	modified Whole-Body Hypothermia	patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure
DEVICE	standard Whole-Body Hypothermia	patients were allocated to standard Whole-Body Hypothermia

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-17
• Last updated: 2023-05-06

Locations

1 site across 1 country: China