Hypoxic Ischemic Encephalopathy of Newborn
Conditions
Interventions
None listed
Sponsors
Kanagawa Children's Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants must meet all 3 inclusion criteria Neonates born at over 36 weeks, birth weight over1800g 1) Perinatal Acidosis based on at least one of the following: pH less than 7.00 in any cord or first infant gas (arterial, venous, or capillary) within 60 min OR base deficit more than16 in any cord or first infant gas (arterial, venous or capillary) within 60 min If pH is between 7.01 and 7.15, OR base deficit is between 10 and 15.9 mmol/l, OR blood gas is not available, an acute perinatal event Apgar score at 10 min less or equal to 5 Continued need for resuscitation at 10 min (chest compressions, bag mask ventilation, or positive pressure ventilation) 2) Mild to severe Encephalopathy on neonatal neurologic exam within 6 hours after birth: defined as presence of at least 2 signs of mild, moderate, or severe encephalopathy.
Exclusion criteria
Exclusion criteria: Congenital or chromosomal anomaly associated with abnormal neurodevelopment or death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary composite outcome of death or mild/ moderate/severe NDI will be assessed at 24 months of age. Impairment is defined as any of the following: cerebral palsy with Gross Motor Function Classification System (GMFCS) level1-5, or the development assessed with the 24 month Ages and Stages Questionnaire (ASQ) Japan below threshold defined as a score lower than 2 standard deviations from the mean on any of the five domains, epilepsy, or hearing loss. | — |
Countries
Japan
Contacts
Public ContactJun Shibasaki
Kanagawa Children's Medical Center Department of Neonatology
Outcome results
None listed