Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

NCT07555652 | Recruiting DMC

• 1 other identifier: 15/HĐ-K2ĐT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxic-ischemic Encephalopathy (HIE)

Outcome Measures

Primary Outcomes (1)

• Survival to hospital discharge

  Proportion of neonates with hypoxic-ischemic encephalopathy (HIE) who survive to hospital discharge following therapeutic hypothermia.

  At hospital discharge (up to 28 days of life)

Secondary Outcomes (2)

• Neurodevelopmental outcome assessed by Bayley Scales of Infant Development III (BSID-III)

  At 24 months of age

• Correlation between Sarnat stage at baseline and neurodevelopmental outcome

  From baseline to 24 months of age

Study Arms (1)

Therapeutic Hypothermia

EXPERIMENTAL

Neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) who meet the protocol-defined eligibility criteria will receive therapeutic hypothermia. Eligible infants are those born at or after 36 weeks of gestation, younger than 6 hours of age, and meeting the required clinical and biochemical criteria for therapeutic hypothermia according to the study protocol.

Procedure: Therapeutic Hypothermia

Interventions

Therapeutic Hypothermia PROCEDURE

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.

Therapeutic Hypothermia

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Vietnam National Children's Hospitalv

Ha Nội, Hanoi, 111111, Vietnam

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Central Study Contacts

DAT HUU TRAN

CONTACT

+84987836686; drtrandat1986@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: This is a non-randomized, prospective interventional study with two parallel groups. Participants will be assigned to either the intervention group (bone marrow mononuclear cell transplantation combined with rehabilitation) or the control group (rehabilitation only). Group allocation is based on clinical and ethical considerations rather than randomization. Comparative analysis will be conducted between the two groups.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 29, 2026
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting documents will be available after completion of the study and publication of the main results. Data will be available from 2028 onward, corresponding to the study completion period, for a reasonable time thereafter.
• Access Criteria: Access to individual participant data and supporting information will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and the institutional authority. Data sharing will be subject to ethical approval and applicable regulations, and data will be de-identified to protect participant confidentiality.

Locations

VN (1)