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

NCT05581927 | Withdrawn

• 1 other identifier: Whole-Body Hypothermia
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• death

  neonates are dead during hospital

  30 days

• brain injury

  neonates are diagnosed with brain injury

  30 days

Secondary Outcomes (6)

• the incidence of suspend of Whole-Body Hypothermia

  within 3 days

• the incidence of discharge according to the doctor's suggestion

  2-3 weeks

• the incidence of intraventricular hemorrhage

  2-3 week

• the incidence of periventricular leukomalacia

  within 30 days

• neurodevelopmental assessment

  one month

Study Arms (2)

modified Whole-Body Hypothermia

EXPERIMENTAL

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

Device: modified Whole-Body Hypothermia

standard Whole-Body Hypothermia

ACTIVE COMPARATOR

patients were allocated to standard Whole-Body Hypothermia.

Device: standard Whole-Body Hypothermia

Interventions

modified Whole-Body Hypothermia DEVICE

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

modified Whole-Body Hypothermia

standard Whole-Body Hypothermia DEVICE

patients were allocated to standard Whole-Body Hypothermia

standard Whole-Body Hypothermia

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• congenital malformation
• parents' refusal

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Model Details: one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 6, 2023

Record last verified: 2022-10

Locations

CN (1)