CompletedNot Applicable

Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

France68 participantsStarted 2019-05-19

Plain-language summary

There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs. There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia. The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.

Who can participate

Age range

2 Years – 7 Years

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: * Full-term children, gestational age\> 36 weeks of amenorrhea * Between the 1st of January 2012 and the 31st of December 2016 * Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon * Perinatal asphyxia with clinical signs of encephalopathy * Indication of therapeutic hypothermia not retained because EAI mild * Where parents were informed and did not object to participation in the study Exclusion Criteria: * Dysmorphic syndrome * Stroke * Children transferred for other criteria (respiratory distress, heart failure ...)

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

Existence of abnormalities

Timeframe: maximum 1 years

Trial details

NCT IDNCT03744481

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-02

View on ClinicalTrials.gov More Anoxic-Ischemic Encephalopathy trials