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

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05581927

Collaborator

Children's Hospital of Chongqing Medical University (Other), Children's Hospital of Suzhou (Other), Women and Children's Hospital of Chongqing (Other), Women and Children's Hospital of Guangxi (Other), People's hospital of Guangyuan (Other)

250

Enrollment

Location

Arms

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxic- Ischemic Encephalopathy Whole-Body Hypothermia Brain Injury	Device: modified Whole-Body Hypothermia Device: standard Whole-Body Hypothermia	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

death [30 days]
neonates are dead during hospital
brain injury [30 days]
neonates are diagnosed with brain injury

Secondary Outcome Measures

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
the incidence of periventricular leukomalacia [within 30 days]
Periventricular leukomalacia is diagnosed
neurodevelopmental assessment [one month]
neurodevelopment is assessed using NBNA
neurodevelopmental assessment [18-36 months]
neurodevelopment is assessed using Bayley scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Hours to 24 Hours

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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