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

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified Whole-Body Hypothermia
standard Whole-Body Hypothermia
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic- Ischemic Encephalopathy

Eligibility Criteria

0 Hours - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

modified Whole-Body Hypothermia

standard Whole-Body Hypothermia

Arm Description

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

patients were allocated to standard Whole-Body Hypothermia.

Outcomes

Primary Outcome Measures

death
neonates are dead during hospital
brain injury
neonates are diagnosed with brain injury

Secondary Outcome Measures

the incidence of suspend of Whole-Body Hypothermia
Whole-Body Hypothermia is suspended
the incidence of discharge according to the doctor's suggestion
neonates were discharged according to the doctor's suggestion
the incidence of intraventricular hemorrhage
intraventricular hemorrhage was diagnosed
the incidence of periventricular leukomalacia
Periventricular leukomalacia is diagnosed
neurodevelopmental assessment
neurodevelopment is assessed using NBNA
neurodevelopmental assessment
neurodevelopment is assessed using Bayley scale

Full Information

First Posted
October 13, 2022
Last Updated
May 4, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05581927
Brief Title
Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)
Official Title
Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no patients were included
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia, Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
modified Whole-Body Hypothermia
Arm Type
Experimental
Arm Description
patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure.
Arm Title
standard Whole-Body Hypothermia
Arm Type
Active Comparator
Arm Description
patients were allocated to standard Whole-Body Hypothermia.
Intervention Type
Device
Intervention Name(s)
modified Whole-Body Hypothermia
Intervention Description
patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure
Intervention Type
Device
Intervention Name(s)
standard Whole-Body Hypothermia
Intervention Description
patients were allocated to standard Whole-Body Hypothermia
Primary Outcome Measure Information:
Title
death
Description
neonates are dead during hospital
Time Frame
30 days
Title
brain injury
Description
neonates are diagnosed with brain injury
Time Frame
30 days
Secondary Outcome Measure Information:
Title
the incidence of suspend of Whole-Body Hypothermia
Description
Whole-Body Hypothermia is suspended
Time Frame
within 3 days
Title
the incidence of discharge according to the doctor's suggestion
Description
neonates were discharged according to the doctor's suggestion
Time Frame
2-3 weeks
Title
the incidence of intraventricular hemorrhage
Description
intraventricular hemorrhage was diagnosed
Time Frame
2-3 week
Title
the incidence of periventricular leukomalacia
Description
Periventricular leukomalacia is diagnosed
Time Frame
within 30 days
Title
neurodevelopmental assessment
Description
neurodevelopment is assessed using NBNA
Time Frame
one month
Title
neurodevelopmental assessment
Description
neurodevelopment is assessed using Bayley scale
Time Frame
18-36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

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

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