Clinical trial Recruiting at 1 site Interventional Ages 0 Hours to 6 Hours

Cooling treatment for newborns with hypoxic-ischemic encephalopathy in Vietnam

Official title: Efficacy of Controlled Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy (HIE)

Run by National Children's Hospital, Vietnam · NCT07555652 · Data updated 2026-11-12

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.

More Hypoxic-Ischemic Encephalopathy trials

Quick facts

Study typeInterventional
Ages0 Hours to 6 Hours
SexAll
Enrollment120 (estimated)
SponsorNational Children's Hospital, Vietnam
Academic / other
Locations1 site (Ha Nội, Hanoi)
StatusRecruiting
StartedJune 10, 2025
Main results expectedMay 1, 2027
Study endsFebruary 1, 2028
Registry record updatedApril 29, 2026
Trial IDNCT07555652 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Multiple international randomized trials have shown therapeutic hypothermia improves outcomes in term infants with HIE, though implementation and standardized protocols vary across countries.

Who can join: the full rules

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 it's running

  • Vietnam National Children's Hospitalv
    Ha Nội, Hanoi, Vietnam
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.