RecruitingNot ApplicableNCT07555652

Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

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


Sponsor

National Children's Hospital, Vietnam

Enrollment

120 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 HoursMax Age: 6 Hours

Inclusion Criteria7

  • 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 Criteria3

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Vietnam National Children's Hospitalv

Ha Nội, Hanoi, Vietnam

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07555652


Related Trials