Vietnam National Children's Hospitalv
Ha Nội, Hanoi, 111111, Vietnam
Location status: Recruiting
NCT Number: NCT07555652
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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Request Info0 hour–6 hour
All sexes
Interventional
Not applicable
Ha Nội, Hanoi, 111111, Vietnam
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
National Children's Hospital, Vietnam
Other
Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
Acronym: HIE-TH Vietnam
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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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