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

NCT03744481 | Completed

• 1 other identifier: 69HCL18_0627
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Full term children with perinatal asphyxia and with clinical signs of mild EAI without indication of therapeutic hypothermia

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Réanimation néonatale - Hôpital de la Croix Rousse

Lyon, 69317, France

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: May 19, 2019
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)