A study of the impact of treating seizures that can be seen and those that can be seen only on a brain monitor in newborn babies, who are having seizures or at high risk of seizures.
- Conditions
- eonatal EncephalopathyNeonatal seizuresHypoxic-ischemic encephalopathy (HIE)Neonatal EncephalopathyNeurological - Other neurological disordersReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12611000327987
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief Summary
There were no significant differences between the two groups. Infants who had all electrographic seizures treated did not have improved mortality or neurodevelopment when compared to those infants who received standard care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 212
Infants greater than or equal to 35 weeks' gestation (term or near term) admitted to a participating Neonatal Intensive Care Unit.
Less than or equal to 48 hours old:
A diagnosis of either:
-Neonatal encephalopathy including coma, stupor or depressed mental state (based on modified Sarnat classification II-III).
-Hypoxic-ischaemic encephalopathy or at risk for hypoxic-ischaemic encephalopathy (ie. 2 of the following - Apgar score less than 5 at 5 minutes); cord blood gas or postnatal blood gas within 1 hour of birth with a pH less than 7.1 or base excess < -12 within 1 hour of birth; need for ongoing respiratory support at 10 minutes after birth)
-suspected neonatal seizures
Infants less than 35 weeks gestation;
Greater than 48 hours old;
Infants in non-convulsive status (as confirmed by conventional electroencephalography taken for one hour as soon as practical);
Infants diagnosed with Cerebral dysgenesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method