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

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.

Study Overview

• Status: Completed
• Conditions: Anoxic-Ischemic Encephalopathy
• Intervention / Treatment: Other: Questionaire

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69317
    • Service de Réanimation néonatale - Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 ...)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2019
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Body Temperature Changes; Hypoxia; Hypoxia, Brain; Brain Ischemia; Ischemia; Brain Diseases; Hypothermia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 69HCL18_0627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No