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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Hypothermia | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to hospital discharge | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 24 months of age |
| Correlation between Sarnat stage at baseline and neurodevelopmental outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAT HUU TRAN | Contact | +84987836686 | drtrandat1986@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Children's Hospitalv | Recruiting | Ha Nội | Hanoi | 111111 | Vietnam |
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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.
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.
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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This is a non-randomized, prospective interventional study with two parallel groups. Participants will be assigned to either the intervention group (bone marrow mononuclear cell transplantation combined with rehabilitation) or the control group (rehabilitation only). Group allocation is based on clinical and ethical considerations rather than randomization. Comparative analysis will be conducted between the two groups.
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|
Correlation between baseline Sarnat stage (ordinal scale) and BSID-III cognitive composite score at 24 months. |
| From baseline to 24 months of age |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |