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Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

Recruiting
6 years and younger
All
Phase N/A

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Overview

This study aims to evaluate the effectiveness of therapeutic hypothermia in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE). The study focuses on assessing both short-term outcomes after treatment and long-term neurological outcomes following therapeutic hypothermia.

Description

Hypoxic-ischemic encephalopathy (HIE) is a major cause of neonatal mortality and long-term neurological impairment, resulting from perinatal hypoxia-ischemia. Therapeutic hypothermia is currently considered a key treatment modality for reducing brain injury and improving outcomes in affected neonates.

This study is designed to:

Develop and standardize technical procedures and indications for therapeutic hypothermia in neonates with HIE Evaluate short-term treatment outcomes following therapeutic hypothermia Assess long-term neurological outcomes after treatment Identify factors associated with treatment outcomes in neonates with HIE

The study will be conducted at the National Children's Hospital, Vietnam, over the period from 2025 to 2028

Eligibility

Inclusion Criteria:

  • Neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) at the Neonatal Center, National Children's Hospital
  • Gestational age ≥ 36 weeks
  • Assessed using the modified Sarnat staging within the first 0-6 hours after birth
  • Eligible for and/or treated with therapeutic hypothermia according to institutional protocol
  • Underwent clinical and paraclinical monitoring during hospitalization
  • Received brain magnetic resonance imaging (MRI) during the neonatal period (from 5 to 17 days of age)
  • Availability of complete medical records for data collection and analysis

Exclusion Criteria:

  • Presence of major congenital anomalies, particularly involving the central nervous system
  • Absence of brain MRI during the study period
  • Refusal of participation by parent(s) or legal guardian(s)

Study details
    Hypoxic-ischemic Encephalopathy (HIE)

NCT07555652

National Children's Hospital, Vietnam

13 May 2026

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