RecruitingNot Applicable

Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam

Vietnam120 participantsStarted 2025-06-10

Plain-language 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.

Who can participate

Age range

0 Hours – 6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival to hospital discharge

Timeframe: At hospital discharge (up to 28 days of life)

Trial details

NCT IDNCT07555652

SponsorNational Children's Hospital, Vietnam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

DAT HUU TRAN

+84987836686 drtrandat1986@gmail.com

View on ClinicalTrials.gov More Hypoxic-ischemic Encephalopathy (HIE) trials

Who can participate

Age range

0 Hours – 6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.