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 range2 Years – 7 Years

SexALL

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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 ...)

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