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

NCT ID: NCT03744481

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-19
• Study Completion Date: 2019-08-02

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.

Conditions

Anoxic-Ischemic Encephalopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Questionaire

Evaluation of psychomotor development in children with mild EAI without indication of therapeutic hypothermia.

Precise analysis of the type (motor, sensory, language, epilepsy) and the severity of sequelae by sending a questionnaire to parents.

Investigation of early, clinical and paraclinical prognostic factors of good or bad neurodevelopmental outcome.

Evaluation of the height-weight growth and the cranial perimeter

Intervention Type: OTHER

Eligibility Criteria

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 ...)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Réanimation néonatale - Hôpital de la Croix Rousse

Lyon, , France

Countries

France

Other Identifiers

69HCL18_0627

Identifier Type: -

Identifier Source: org_study_id