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NCT Number: NCT07555652

Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

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.

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Key information

Age range

0 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam National Children's Hospitalv

Ha Nội, Hanoi, 111111, Vietnam

Location status: Recruiting

Location contact

DAT HUU TRAN

CONTACT

[email protected]

+84-987836686

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Therapeutic Hypothermia

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DAT HUU TRAN

CONTACT

[email protected]

+84987836686

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Registry information

Official study title

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

Acronym: HIE-TH Vietnam

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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