Table 2.
Seizures and anti-seizure medications (ASM) of 150 neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia and treated with erythropoietin or placebo who received continuous video-EEG throughout hypothermia and rewarming.
| Total N=150 | Erythropoietin N= 83 | Placebo N=67 | aRR (95% CI)* | P value * | |
|---|---|---|---|---|---|
| Seizures and Seizure Timing | |||||
| N (%) with EEG seizures** | 46 (31%) | 26 (31%) | 20 (30%) | 1.04 (0.60, 1.80) | 0.88 |
| With moderate encephalopathy | 29/117 (25%) | 16/64 (23%) | 13/53 (24%) | 0.98 (0.41, 2.34) | |
| With severe encephalopathy | 17/33 (52%) | 10/19 (53%) | 7/14 (50%) | 1.03 (0.62, 1.72) | |
| After 1st dose of study drug | 40 (27%) | 22 (27%) | 18 (27%) | 0.88 (0.44, 1.76) | 0.72 |
| Between 1st and 2nd dose of study drug | 34 (23%) | 19 (23%) | 15 (22%) | 0.88 (0.45, 1.73) | 0.71 |
| After 2nd dose of study drug | 16 (11%) | 11 (13%) | 5 (7.5%) | 1.12 (0.41, 3.07) | 0.83 |
| ASM Administration | |||||
| N (%) administered ASM | 66 (44%) | 30 (36%) | 36 (54%) | 0.60 (0.40, 0.89) | 0.01 |
| Phenobarbital | 64 (43%) | 29 (35%) | 35 (52%) | 0.62 (0.41, 0.93) | 0.02 |
| Levetiracetam | 33 (22%) | 12 (15%) | 11 (16%) | 0.73 (0.34, 1.60) | 0.44 |
| Phenytoin/Fosphenytoin | 13 (8.7%) | 7 (8.4%) | 6 (9.0%) | 1.06 (0.39, 2.88) | 0.91 |
| Other (midazolam, lorazepam, topiramate) | 65 (43%) | 34 (41%) | 31 (46%) | 0.91 (0.61, 1.34) | 0.62 |
aRR adjusted relative risk; EEG electroencephalogram; ASM anti-seizure medication
*
Adjusted relative risks and P values based upon generalized (binary) logistic regression model and adjusts for treatment, HIE severity, and recruitment site.
**
Logistic regression models additionally adjusted for the maximum seizure minutes/hour observed prior to first study drug dosing, and a log offset log(Tj) to account for variable lengths of cEEG observation time overall or between study drug doses.