Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic Hypothermia.
- Who it may be relevant to
- Registry conditions: Hypoxic-ischemic Encephalopathy (HIE). Basic parameters: 0 Hours — 6 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
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.
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
Interventions
- 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.
Primary outcome measures
- Survival to hospital discharge [Time frame: At hospital discharge (up to 28 days of life)]
Secondary outcome measures (2)
- Neurodevelopmental outcome assessed by Bayley Scales of Infant Development III (BSID-III) [Time frame: At 24 months of age]
- Correlation between Sarnat stage at baseline and neurodevelopmental outcome [Time frame: From baseline to 24 months of age]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- Vietnam National Children's Hospitalv — Ha Nội
Identifiers
NCT: NCT07555652 · 15/HĐ-K2ĐT