Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam (HIE-TH Vietnam)

April 21, 2026 updated by: Dat Tran, National Children's Hospital, Vietnam

Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
    • Hanoi
      • Ha Nội, Hanoi, Vietnam, 111111
        • Recruiting
        • Vietnam National Children's Hospitalv
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Hypothermia
Neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) who meet the protocol-defined eligibility criteria will receive therapeutic hypothermia. Eligible infants are those born at or after 36 weeks of gestation, younger than 6 hours of age, and meeting the required clinical and biochemical criteria for therapeutic hypothermia according to the study protocol.
Procedure: Therapeutic Hypothermia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to hospital discharge
Time Frame: At hospital discharge (up to 28 days of life)
Proportion of neonates with hypoxic-ischemic encephalopathy (HIE) who survive to hospital discharge following therapeutic hypothermia.
At hospital discharge (up to 28 days of life)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopmental outcome assessed by Bayley Scales of Infant Development III (BSID-III)
Time Frame: At 24 months of age
Cognitive, language, and motor composite scores assessed using BSID-III in infants treated with therapeutic hypothermia for HIE.
At 24 months of age
Correlation between Sarnat stage at baseline and neurodevelopmental outcome
Time Frame: From baseline to 24 months of age
Correlation between baseline Sarnat stage (ordinal scale) and BSID-III cognitive composite score at 24 months.
From baseline to 24 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Hospital, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/HĐ-K2ĐT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Individual participant data (IPD) and supporting documents will be available after completion of the study and publication of the main results. Data will be available from 2028 onward, corresponding to the study completion period, for a reasonable time thereafter.

IPD Sharing Access Criteria

Access to individual participant data and supporting information will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and the institutional authority. Data sharing will be subject to ethical approval and applicable regulations, and data will be de-identified to protect participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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