Informations générales (source: ClinicalTrials.gov)
Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia (LyTONEPAL)
Observational
University Hospital, Grenoble (Voir sur ClinicalTrials)
septembre 2015
mars 2021
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Fabrice DECOBERT | 29/03/2024 01:26:39 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chru Lille - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Chu Amiens - 80000 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Chu Besancon - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Chu Bordeaux - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Chu Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU CAEN - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU Clermond-Ferrand - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Chu Dijon - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU FORT de France - 97200 - Fort De France - France | Contact (sur clinicalTrials) | ||||
| Chu Grenoble - 38000 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Chu La Miletrie - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Chu Marseille - 13000 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - 34000 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Chu Reims - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Chu Rouen - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU St Denis - 97400 - Saint-Denis De La Réunion - France | Contact (sur clinicalTrials) | ||||
| CHU St Pierre - 97410 - Saint-Pierre - France | Contact (sur clinicalTrials) | ||||
| Chu Strasbourg - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Chu Toulouse - 31000 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Chu Tours - 37000 - Tours - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Infants born at a gestational age of 34 weeks or more;
- Presenting early neurological distress with clinical signs of moderate to severe HIE
at a standardized neurologic examination performed by a senior examiner:
- Moderate HIE: lethargy, hyper-reflexia, miosis, bradycardia, seizures,
hypotonia with weak suck and Moro reflex
- Severe HIE: stupor, flaccidity, small to mid-position pupils that react poorly
to light, reduced stretch reflexes, hypothermia or no Moro reflex
- With criteria for asphyxia:
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of
umbilical-cord blood or any blood sampled in the first hour after birth.
- If, during this interval, the pH is between 7.01 and 7.15, base deficit is
between 10 and 15.9 mmol per liter, or blood gas is not available, additional
criteria will be required. These include:
- an acute perinatal event (e.g., late or variable decelerations, cord prolapse,
cord rupture, uterine rupture, maternal trauma, hemorrhage, or
cardiorespiratory arrest)
- or an abrupt change in fetal heart rate (FHR), defined as a persistent abnormal
FHE after a period of normal tracing: bradycardia or prolonged deceleration,
persistent variable decelerations, persistent late decelerations, and reduced
heart variability
- or either a 10-minute Apgar score of 5 or less or assisted ventilation
initiated at birth and continued for at least 10 minutes.
- Written parental informed consent
- Covered by the French social security
- Infants born at a gestational age of 34 weeks or more;
- Presenting early neurological distress with clinical signs of moderate to severe HIE
at a standardized neurologic examination performed by a senior examiner:
- Moderate HIE: lethargy, hyper-reflexia, miosis, bradycardia, seizures,
hypotonia with weak suck and Moro reflex
- Severe HIE: stupor, flaccidity, small to mid-position pupils that react poorly
to light, reduced stretch reflexes, hypothermia or no Moro reflex
- With criteria for asphyxia:
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of
umbilical-cord blood or any blood sampled in the first hour after birth.
- If, during this interval, the pH is between 7.01 and 7.15, base deficit is
between 10 and 15.9 mmol per liter, or blood gas is not available, additional
criteria will be required. These include:
- an acute perinatal event (e.g., late or variable decelerations, cord prolapse,
cord rupture, uterine rupture, maternal trauma, hemorrhage, or
cardiorespiratory arrest)
- or an abrupt change in fetal heart rate (FHR), defined as a persistent abnormal
FHE after a period of normal tracing: bradycardia or prolonged deceleration,
persistent variable decelerations, persistent late decelerations, and reduced
heart variability
- or either a 10-minute Apgar score of 5 or less or assisted ventilation
initiated at birth and continued for at least 10 minutes.
- Written parental informed consent
- Covered by the French social security
- Congenital malformations
- Chromosomal disorders
- Congenital neuromuscular disorders