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

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.

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

Conditions
-----------------
Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia, Brain Injury

Intervention / Treatment
-----------------
* Device: modified Whole-Body Hypothermia
* Device: standard Whole-Body Hypothermia


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Hours
Maximum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified Whole-Body Hypothermia<br>patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure. | Device: modified Whole-Body Hypothermia<br>* patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure<br>|
| Active Comparator: standard Whole-Body Hypothermia<br>patients were allocated to standard Whole-Body Hypothermia. | Device: standard Whole-Body Hypothermia<br>* patients were allocated to standard Whole-Body Hypothermia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | neonates are dead during hospital | 30 days | 
| brain injury | neonates are diagnosed with brain injury | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of suspend of Whole-Body Hypothermia | Whole-Body Hypothermia is suspended | within 3 days | 
| the incidence of discharge according to the doctor's suggestion | neonates were discharged according to the doctor's suggestion | 2-3 weeks | 
| the incidence of intraventricular hemorrhage | intraventricular hemorrhage was diagnosed | 2-3 week | 
| the incidence of periventricular leukomalacia | Periventricular leukomalacia is diagnosed | within 30 days | 
| neurodevelopmental assessment | neurodevelopment is assessed using NBNA | one month | 
| neurodevelopmental assessment | neurodevelopment is assessed using Bayley scale | 18-36 months |