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Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment

NCT02676063 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2018-06-06

No results posted yet for this study

Summary

The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE.

Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list:

* Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer
* Laboratory investigations: pH, lactates and new biological markers as detailed below
* Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI

Conditions

  • Ischemic-Hypoxic Encephalopathy

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Thierry DEBILLON, MD PhD · University Hospital, Grenoble

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-03-31
Completion
2021-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02676063 on ClinicalTrials.gov