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

Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05581927
• Other study ID #: Whole-Body Hypothermia
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injury
• Brain Ischemia
• Hypothermia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Device:
• modified Whole-Body Hypothermia
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

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (6)

Lead Sponsor	Collaborator
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, People's hospital of Guangyuan, Women and Children's Hospital of Chongqing, Women and Children's Hospital of Guangxi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	neonates are dead during hospital	30 days
Primary	brain injury	neonates are diagnosed with brain injury	30 days
Secondary	the incidence of suspend of Whole-Body Hypothermia	Whole-Body Hypothermia is suspended	within 3 days
Secondary	the incidence of discharge according to the doctor's suggestion	neonates were discharged according to the doctor's suggestion	2-3 weeks
Secondary	the incidence of intraventricular hemorrhage	intraventricular hemorrhage was diagnosed	2-3 week
Secondary	the incidence of periventricular leukomalacia	Periventricular leukomalacia is diagnosed	within 30 days
Secondary	neurodevelopmental assessment	neurodevelopment is assessed using NBNA	one month
Secondary	neurodevelopmental assessment	neurodevelopment is assessed using Bayley scale	18-36 months