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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Brain Injury; Hypoxic- Ischemic Encephalopathy; Whole-Body Hypothermia
• Intervention / Treatment: Device: modified Whole-Body Hypothermia; Device: standard Whole-Body Hypothermia

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen（陈） Long, MD, PhD; Phone Number: +8613883559467; Email: neuroclong@126.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Children's Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Chongqing Medical University; Children's Hospital of Suzhou; Women and Children's Hospital of Chongqing; Women and Children's Hospital of Guangxi; People's hospital of Guangyuan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms, Respiratory; Body Temperature Changes; Hypoxia, Brain; Brain Ischemia; Ischemia; Brain Injuries; Brain Diseases; Hypoxia; Hypothermia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: Whole-Body Hypothermia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No