Induced systemic hypothermia in asphyxiated new-born infants: a randomised, controlled, multicentre study
- Conditions
- P21Birth asphyxia
- Registration Number
- DRKS00000102
- Lead Sponsor
- Medizinische Universität InnsbruckUniversitätsklinik für Pädiatrie IV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 129
A: Evidence of severe birth asphyxia in infants >= 36 weeks gestation admitted to NICI: one of the following:
- Apgar score of <= 5 at 10 minutes after birth
- continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
- Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth < 7.0
B: Evidence of encephalopathy (assessed by certified study personnel): moderate to severe encephalopathy
C: Evidence of moderate to severe neurophysiological dysfunction by EEG or aEEG
D: Consent of at least one parent.
- Infants expected to be >5.5 hours of age at the time of randomization
- prophylactic administration of high dose anticonvulsants
- major congenital abnormalities
- imperforate anus
- evidence of head trauma or skull fracture causing major intracranial hemorrhage
- Infants < 1800g birth weight
- Head circumference < (mean - 2sd) for gestation
- Infants in extremis
- overt bleeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at 18-21 months of postnatal age free of severe neurological handicap
- Secondary Outcome Measures
Name Time Method general developmental quotient (Griffiths test or alternatives) in the subgroups of infants with moderate or severe HIE || Neurological deficit by Thompson score one week postnatal || head circumference at age of 6 months || Adverse events (primarily those monitored during intervention period)