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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03744481
Acronym
SARNATUN
Enrollment
68
Registered
2018-11-16
Start date
2019-05-19
Completion date
2019-08-02
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anoxic-Ischemic Encephalopathy

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.

Interventions

OTHERQuestionaire

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years

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 ...)

Design outcomes

Primary

MeasureTime frameDescription
Existence of abnormalitiesmaximum 1 yearsAbnormalities 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026