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

Not Applicable

Withdrawn

• Conditions: Brain Injury; Hypoxic- Ischemic Encephalopathy; Whole-Body Hypothermia
• Interventions: Device: modified Whole-Body Hypothermia; Device: standard Whole-Body Hypothermia

• Registration Number: NCT05581927
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
death	30 days	neonates are dead during hospital
brain injury	30 days	neonates are diagnosed with brain injury

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China