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

Anoxic-Ischemic Encephalopathy Clinical Trial

— SARNATUN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744481
• Other study ID #: 69HCL18_0627
• Status: Completed
• Start date: May 19, 2019
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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 ...)

Related Conditions & MeSH terms

• Anoxic-Ischemic Encephalopathy
• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Service de Réanimation néonatale - Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of abnormalities	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.	maximum 1 years