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

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.

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Key information

Conditions

Anoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Réanimation néonatale - Hôpital de la Croix Rousse

Lyon, 69317, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

Questionaire

Other

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

Primary outcomes

Existence of abnormalities

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SARNATUN

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Nov 16, 2018
Registry last updated: Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed