Hypoxic-ischemic Encephalopathy (HIE)
Conditions
Brief summary
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
PROCEDURETherapeutic 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.
Sponsors
National Children's Hospital, Vietnam
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival to hospital discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental outcome assessed by Bayley Scales of Infant Development III (BSID-III) | At 24 months of age | Cognitive, language, and motor composite scores assessed using BSID-III in infants treated with therapeutic hypothermia for HIE. |
| Correlation between Sarnat stage at baseline and neurodevelopmental outcome | From baseline to 24 months of age | Correlation between baseline Sarnat stage (ordinal scale) and BSID-III cognitive composite score at 24 months. |
Countries
Vietnam
Contacts
CONTACTDAT HUU TRAN
Outcome results
None listed