Neonatal encephalopathy
Conditions
Interventions
Induced whole-body cooling with a target core body temoerature of 33.5C for 72 hours
Sponsors
Kurume University School of Medicine
Committee on Resuscitation, Japan Society of Perinatal and Neonatal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Neonates are first assessed using the standard criteria for therapeutic hypothermia* (Shankaran et al. NEJM 2005). 1. Neonates born at 36 weeks gestation or greater, and body weight >1799g 2. Postnatal age < 6 hours after birth 3. At least one of the following criteria: - Apgar score 0-5 at 10 minutes - Cord or first postnatal blood pH less than 7.0 - Cord or first postnatal blood Base deficit greater than 16 mEq/L - Need for continued resuscitation at least 10 minutes 4. Abnormal neurological exam suggesting the presence of moderate or severe encephalopathy Neonates who meet 3 of 4 criteria are assessed for eligibility using the following entry criteria. Category 1: Neonates < 36 weeks gestation but > 33 0/7 weeks, and/or body weight between 1500g and 1799g. Category 2: Neonates between 6 and 12 hours of birth when cooling is initiated. Category 3: At least one of the following criteria: - Apgar 0-5 at 5 minutes - pH less than 7.1 - Base deficit greater than 10 mEq/L Category 4: Abnormal neurological exam suggesting the presence of mild encephalopathy
Exclusion criteria
Exclusion criteria: Gestational age <33 weeks or body weight <1500g. Older than 12 hours of birth. Neonates deemed inappropriate for cooling because of critical clinical conditions, such as severe haemorrhagic diathesis, congenital malformations, infection and cardiopulmonary failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or severe adverse events until hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Days on mechanical ventilation Age at hospital discharge Requirement for tube-feeding at discharge Death or moderate disability (Time Frame: Birth to 18-22 months corrected age) Brain MRI findings (Time Frame: 5-14 days) | — |
Countries
Japan
Contacts
Public ContactKennosuke Tsuda
Yokohama City University Medical Center Pediatrics
Outcome results
None listed