Neonatal Diseases
Conditions
Interventions
Morphine in children cooled for HIE
Cooling No Morphine
Sponsors
SAMRC
Mary Rutherford
Department of Paediatrics and Child Health
Prof B Marais
Helena Rabie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 36 weeks gestation or greater 2) Birthweight of at least 1.8kg. 3) At least one of the following: a) need for resuscitation for =10 minutes, b) Apgar score =7 at 10 minutes, c)pH =7 or base deficit =16 on cord gas or infant blood within an hour of birth. 4) Seizures, or moderate to severe encephalopathy on clinical grounds, or a Thompson HIE score of at least 10 5) Less than 6 hours old at initiation of cooling
Exclusion criteria
Exclusion criteria: 1) Less than 36 weeks 2) Birthweight less than 1.8kg. 3) Not meeting at least one of the following: a) need for resuscitation for =10 minutes, b) Apgar score =7 at 10 minutes, c)pH =7 or base deficit =16 on cord gas or infant blood within an hour of birth. 4) No Seizures and NO moderate to severe encephalopathy on clinical grounds, or a Thompson HIE score of at least 10 5) Older than 6 hours 6) congenital abnormalities 7) infants in whom intensive care is withdrawn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: to determine whether combining therapeutic hypothermia with another neuroprotective strategy (ie. morphine) improves survival to 18 months of age, and improves survival without major disability at 18 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of several biomarkers with the severity of the primary injury and outcome will be evaluated. | — |
Countries
South Africa
Contacts
Public ContactAnita Fourie
Stellenbosch University
Outcome results
None listed