Avasiloaiei 2013.
Methods | Single‐center randomized controlled trial in Romania | |
Participants | Included 67 term neonates with severe perinatal asphyxia (defined as having 3 of 4 criteria (umbilical artery blood pH < 7.0 with or without base deficit ≥ 12 mEq/L, Apgar ≤ 3 at > 5 minutes of life, neonatal neurologic sequelae (i.e. seizures, coma, hypotonia) or multiple organ involvement (i.e. kidney, lungs, liver, heart, intestines)) without major congenital malformations or hemolytic disease due to Rh incompatibility | |
Interventions | Randomized into 1 of 3 groups Phenobarbital group (n = 22) received conventional supportive therapy plus a phenobarbital loading dose (40 mg/kg IV) during the first 4 hours after birth Erythropoietin group (n = 22) received conventional supportive therapy plus subcutaneous erythropoietin (1000 IU/kg per day) for 3 days Supportive therapy group (n = 23) received conventional supportive therapy including oxygen, volume expanders, inotropes, diuretics, antibiotics, and anticonvulsants for clinically suspected seizures confirmed by aEEG |
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Outcomes | Serum levels of antioxidant enzymes (SOD and GPx), TAS, and lipid peroxidation (using MDA levels) at 4, 24, 48, and 72 hours and at 7 days of life Death, seizures (confirmed by aEEG), neurologic abnormalities on examination at > 72 hours of life and at the time of discharge (exam as per Amiel‐Tison) and long‐term neurologic outcome (assessed at 3, 6, 9, 12, and 18 months of age using Bayley II assessment) |
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Notes | Long‐term neurodevelopmental data were reported as percentages, unpublished incidence data were requested, provided, and included. Seizure data were reported as number of infants at a given time, unpublished incidence data were requested, provided, and included | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐draw numerical assignment |
Allocation concealment (selection bias) | High risk | Treatment team was not blinded to allocation |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of the treatment team or assessors. No placebo used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data was complete to 100% |
Selective reporting (reporting bias) | Low risk | All outcomes were reported Long‐term neurodevelopmental data were reported as percentages, unpublished incidence date were requested, provided, and included Seizure data were reported as number of infants at a given time, unpublished incidence data were requested, provided, and included |