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

Completed

• Conditions: Anoxic-Ischemic Encephalopathy

• Registration Number: NCT03744481
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Study Start: 2019-05-19
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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Exclusion Criteria

• Dysmorphic syndrome
• Stroke
• Children transferred for other criteria (respiratory distress, heart failure ...)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Existence of abnormalities	maximum 1 years	Abnormalities researched are : abnormal motor, sensory (auditory or visual), delayed psychomotor acquisition compared to the expected (norms), or epilepsy at 2 years.; These anomalies will be collected by sending a questionnaire to the parents.

Trial Locations

Locations (1)

Service de Réanimation néonatale - Hôpital de la Croix Rousse; 🇫🇷 Lyon, France