Status:
COMPLETED
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
Lead Sponsor:
Meyer Children's Hospital IRCCS
Collaborating Sponsors:
Azienda Ospedaliero, Universitaria Pisana
Conditions:
Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
36+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia...
Detailed Description
Neonatal hypoxic-ischemic encephalopathy, due to perinatal asphyxia, is one of the leading causes of cerebral palsy, whose incidence, despite improvements in perinatal practice and neonatal care, has ...
Eligibility Criteria
Inclusion
- Gestational age \> 36 weeks and birth weigh \> 1800 g with at least 1 of the following: a) Apgar score \< 5 at 10 minutes; b) persisting need for resuscitation, including endotracheal intubation or mask ventilation 10 minutes after birth; c) acidosis (pH \<7.0, base deficit \>-16 mmol/L in umbilical cord blood or arterial, venous or capillary blood) within 60 minutes from birth;
- moderate to severe encephalopathy, consisting of altered state of consciousness (irritability, lethargy, stupor, or coma) and \> 1 of the following sings: a) hypotonia, b) abnormal reflexes, including oculomotor or pupil abnormalities, c) absent or weak suck, d) clinical seizures.
- abnormal aEEG
Exclusion
- congenital abnormalities, congenital viral infections or evidence encephalopathy other than HIE.
- \-
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01241019
Start Date
February 1 2010
End Date
December 1 2013
Last Update
December 13 2013
Active Locations (2)
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1
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer
Florence, Italy, I-50139
2
Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, I-56100