Clinical Trial Details
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NCT02676063 : Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment
AgesMin: N/A Max: N/A
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

- 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

Exclusion Criteria:

- Congenital malformations

- Chromosomal disorders

- Congenital neuromuscular disorders
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