P21
Conditions
Interventions
Group 1: Hypothermia :
nursed naked on a cooling matress which is perfused by circulating water at a variable temperature and covered by normal linen. The infant will have diaper aroound the lower hal
Sponsors
Medizinische Universität Innsbruck
Universitätsklinik für Pädiatrie IV
Eligibility
Sex/Gender
All
Age
0 Days to 0 Days
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival at 18-21 months of postnatal age free of severe neurological handicap | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Singapore, South Africa
Contacts
Public ContactGeorg Simbruner
Medizinische Universität Innsbruck Universitätsklinik für Pädiatrie IV
Outcome results
None listed