Actively Recruiting
Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
Led by National Children's Hospital, Vietnam · Updated on 2026-04-29
120
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate therapeutic hypothermia as a treatment for newborns diagnosed with hypoxic-ischemic encephalopathy (HIE), a serious condition caused by lack of oxygen and blood flow around birth that can lead to death or long-term brain problems. The study focuses on measuring both the short-term results after treatment and the long-term neurological development of these infants. Eligible newborns who are at least 36 weeks gestation and younger than 6 hours old will receive therapeutic hypothermia following a standardized protocol. This treatment involves controlled cooling of the infant's body to reduce brain injury. Continuous clinical and neurological monitoring will be done throughout the treatment period. The study takes place from 2025 to 2028 at the National Children's Hospital in Vietnam. Participants will undergo clinical and laboratory monitoring during their hospital stay, including brain MRI scans between 5 and 17 days after birth. Researchers will track survival up to hospital discharge and assess neurodevelopment at 24 months using specialized scales. Data collection will include medical records and neurological assessments, aiming to identify factors related to treatment outcomes. The total observation period spans from birth through 24 months of age.
CONDITIONS
Brief Title
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) at the Neonatal Center, National Children's Hospital
- Gestational age 236 weeks or more
- 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
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Within 6 hours after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 28 days (until hospital discharge)
Participants receive therapeutic hypothermia with continuous clinical and neurologic monitoring during hospitalization.
Continuous monitoring during hospitalization
Duration - Up to 24 months after treatment
Participants are assessed for neurodevelopmental outcomes and correlation with initial clinical status up to 24 months of age.
Visits for neurodevelopmental assessment at 24 months of age
Trial Site Locations
Total: 1 location
1
Vietnam National Children's Hospitalv
Ha Nội, Hanoi, Vietnam, 111111
Actively Recruiting
Research Team
D
DAT HUU TRAN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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