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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hypoxic- Ischemic Encephalopathy Whole-Body Hypothermia Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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modified Whole-Body Hypothermia

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

Group Type EXPERIMENTAL

modified Whole-Body Hypothermia

Intervention Type DEVICE

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

standard Whole-Body Hypothermia

patients were allocated to standard Whole-Body Hypothermia.

Group Type ACTIVE_COMPARATOR

standard Whole-Body Hypothermia

Intervention Type DEVICE

patients were allocated to standard Whole-Body Hypothermia

Interventions

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modified Whole-Body Hypothermia

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

Intervention Type DEVICE

standard Whole-Body Hypothermia

patients were allocated to standard Whole-Body Hypothermia

Intervention Type DEVICE

Eligibility Criteria

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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