Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorNational Children's Hospital, Vietnam
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Therapeutic Hypothermia
Procedure/SurgeryTherapeutic 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Therapeutic HypothermiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Survival to hospital discharge
Proportion of neonates with hypoxic-ischemic encephalopathy (HIE) who survive to hospital discharge following therapeutic hypothermia.
Time frame
At hospital discharge (up to 28 days of life)Secondary outcomes
1
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.
Time frame
At 24 months of age2
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.
Time frame
From baseline to 24 months of ageLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Vietnam National Children's HospitalvRecruiting111111, Ha Nội, Hanoi
Vietnam
VietnamSponsors and contacts
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Source ClinicalTrials.gov