Hypoxic-ischemic Encephalopathy (HIE)HIE-TH VietnamNCT07555652
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
A study testing Therapeutic Hypothermia in people with Hypoxic-ischemic Encephalopathy (HIE), run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Hypoxic-ischemic Encephalopathy (HIE)
- What is being tested?
- Therapeutic Hypothermia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Jun 2025to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Vietnam National Children's Hospitalv
Ha Nội, Hanoi, 111111
DAT HUU TRAN, +84-987836686, drtrandat1986@gmail.com
About this study
Official title: Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
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.
Read the 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
- Conditions
- Hypoxic-ischemic Encephalopathy (HIE)
- Being tested
- Therapeutic Hypothermia
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic HypothermiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Therapeutic Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Proportion of neonates with hypoxic-ischemic encephalopathy (HIE) who survive to hospital discharge following therapeutic hypothermia.
Measured: At hospital discharge (up to 28 days of life)
Secondary outcomes (2)
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.
Measured: At 24 months of age
Correlation between Sarnat stage at baseline and neurodevelopmental outcome
Correlation between baseline Sarnat stage (ordinal scale) and BSID-III cognitive composite score at 24 months.
Measured: From baseline to 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start10 Jun 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-ischemic Encephalopathy (HIE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dat Tran, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555652
- Sponsor's protocol ID
- 15/HĐ-K2ĐT
- Acronym
- HIE-TH Vietnam
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
- ClinicalTrials.gov ID
- NCT07555652
- Acronym / sponsor ID
- HIE-TH Vietnam / 15/HĐ-K2ĐT
- Conditions
- Hypoxic-ischemic Encephalopathy (HIE)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Hypothermia | Experimental | Procedure: Therapeutic HypothermiaNeonates 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. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic HypothermiaTherapeutic 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. | Procedure or surgery | Therapeutic Hypothermia |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Hypothermia in people with Hypoxic-ischemic Encephalopathy (HIE), run by National Children's Hospital, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAT HUU TRAN (+84987836686, drtrandat1986@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to hospital discharge (time frame: At hospital discharge (up to 28 days of life)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.