Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
Conditions
Keywords
Interleukin 1-beta, Interleukin 6, Vitamin C, HIE, neonates
Brief summary
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.
Interventions
IV, 100 mg/kg/day, every day, for 3 days
DRUGIbuprofen
PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
DRUGPlacebo
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Hours
Healthy volunteers
No
Inclusion criteria
* Apgar score at 5 minutes \< 6 * Profound metabolic or mixed acidosis with pH \< 7 in the initial blood gas * Evidence of encephalopathy such as coma, seizures or hypotonia * Evidence of multi-system compromise, in addition to encephalopathy
Exclusion criteria
* Major congenital anomalies * Early sepsis * Gastrointestinal bleeding * Thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DDST-II | 6 months |
| Neurological Examination | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Death | On Discharge |
| Neurological Examination | On Discharge |
Countries
Egypt
Outcome results
None listed