Cooling treatment for newborns with hypoxic-ischemic encephalopathy in Vietnam
Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
This project will test whether cooling (therapeutic hypothermia) helps newborns with hypoxic-ischemic encephalopathy in Vietnam by looking at short-term recovery and long-term brain outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 0 Hours to 6 Hours |
| Sex | All |
| Sponsor | National Children's Hospital, Vietnam Academic / other |
| Locations | 1 site (Ha Nội, Hanoi) |
| Trial ID | NCT07555652 on ClinicalTrials.gov |
What this trial studies
Researchers at the National Children's Hospital in Hanoi will apply standardized therapeutic hypothermia protocols to term newborns (≥36 weeks) with hypoxic-ischemic encephalopathy identified within 6 hours of birth. Clinical and paraclinical monitoring will be performed during hospitalization and brain MRI will be obtained between days 5 and 17 of life. Short-term treatment outcomes will be recorded and long-term neurological outcomes will be followed through the 2025–2028 study period. The team will also analyze factors associated with outcomes to refine technical procedures and indications for cooling.
Who should consider this trial
Good fit: Term newborns (gestational age ≥36 weeks) diagnosed with HIE within 0–6 hours of birth who are eligible for therapeutic hypothermia and treated at the National Children's Hospital are the intended participants.
Not a fit: Infants with major congenital central nervous system anomalies, very preterm infants (<36 weeks), those who do not receive brain MRI during the neonatal period, or families who decline participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce neonatal brain injury and improve survival and long-term neurodevelopment for infants with HIE in Vietnam.
How similar studies have performed: Multiple international randomized trials have shown therapeutic hypothermia improves outcomes in term infants with HIE, though implementation and standardized protocols vary across countries.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Ha Nội, Hanoi
- Vietnam National Children's Hospitalv — Ha Nội, Hanoi, Vietnam (Recruiting)
Study contacts
- Study coordinator: Dat Huu Tran
- Email: drtrandat1986@gmail.com
- Phone: +84987836686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.