Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

National Children's Hospital, Vietnam120 enrolled

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Hypoxic-ischemic Encephalopathy (HIE)

Interventions

Therapeutic HypothermiaPROCEDURE

Therapeutic hypothermia will be administered to neonates with HIE according to the protocolized technical procedure developed and standardized in the study. The intervention is initiated in eligible neonates within 6 hours after birth and is performed with continuous clinical and neurologic monitoring as specified in the protocol.

Eligibility

Sex: ALLMin age: 0 HoursMax age: 6 Hours

Medical Language ↔ Plain English

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)

Locations (1)

Vietnam National Children's Hospitalv

Ha Nội, Hanoi, Vietnam

RECRUITING

Outcomes

Primary Outcomes

Survival to hospital discharge

Proportion of neonates with hypoxic-ischemic encephalopathy (HIE) who survive to hospital discharge following therapeutic hypothermia.

Time frame: At hospital discharge (up to 28 days of life)

Secondary Outcomes

Neurodevelopmental outcome assessed by Bayley Scales of Infant Development III (BSID-III)

Cognitive, language, and motor composite scores assessed using BSID-III in infants treated with therapeutic hypothermia for HIE.

Time frame: At 24 months of age

Correlation between Sarnat stage at baseline and neurodevelopmental outcome

Correlation between baseline Sarnat stage (ordinal scale) and BSID-III cognitive composite score at 24 months.

Time frame: From baseline to 24 months of age

Central Contacts

DAT HUU TRAN

CONTACT

+84987836686 drtrandat1986@gmail.com

Data from ClinicalTrials.gov

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