Table 1.
Baseline clinical and electroencephalogram (EEG) characteristic 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 | p-value* | |
|---|---|---|---|---|
| Maternal Characteristics, n (%) | ||||
| Race | 0.59 | |||
| White | 104 (69%) | 58 (70%) | 46 (69%) | |
| Black | 18 (12%) | 8 (9.6%) | 10 (15%) | |
| Asian | 15 (10%) | 8 (9.6%) | 7 (10%) | |
| Other | 13 (8.7%) | 9 (11%) | 4 (6.0%) | |
| Hispanic ethnicity | 33 (22%) | 16 (19%) | 17 (25%) | 0.37 |
| Age (years), mean (SD) | 30.1 (6.6) | 30.8 (6.9) | 29.3 (6.3) | 0.16 |
| Education, high school or less | 58 (39%) | 33 (40%) | 25 (37%) | 0.76 |
| Parity = 1 (including subject) | 91 (61%) | 52 (63%) | 39 (58%) | 0.58 |
| Pregnancy and Delivery Complications, n (%) | ||||
| Maternal chorioamnionitis or fever | 28 (19%) | 15 (18%) | 13 (19%) | 0.84 |
| Maternal pre-eclampsia or eclampsia | 16 (11%) | 8 (10%) | 8 (12%) | 0.65 |
| Gestational diabetes | 14 (9.3%) | 6 (7.2%) | 8 (12%) | 0.32 |
| Maternal obesity (BMI >30) | 25 (17%) | 15 (18%) | 10 (15%) | 0.61 |
| Sentinel eventa | 48 (32%) | 26 (31%) | 22 (33%) | 0.85 |
| Cesarean section delivery | 99 (66%) | 57 (69%) | 42 (63%) | 0.33 |
| Infant Characteristics | ||||
| Female, n (%) | 65 (43%) | 33 (40%) | 32 (48%) | 0.44 |
| Birth weight (grams), mean (SD) | 3411 (558) | 3354 (542) | 3481 (573) | 0.14 |
| Gestational age (weeks), mean (SD) | 39.2 (1.5) | 39.1 (1.4) | 39.3 (1.4) | 0.26 |
| 5-minute Apgar score, median (IQR) | 3 (2, 4) | 3 (2, 4) | 4 (2, 5) | 0.26 |
| Lowest pHb, mean (SD) | 6.9 (0.2) | 6.9 (0.2) | 6.9 (0.2) | 0.79 |
| Worst base deficitb, mean (SD) | 17.6 (6.1) | 17.1 (5.6) | 18.2 (6.6) | 0.54 |
| Severe encephalopathyc, n (%) | 33 (22%) | 19 (23%) | 14 (21%) | 0.77 |
| cEEG Monitoring | ||||
| cEEG starting hour after birth, median (IQR) | 8.4 (6.4, 10.3) | 7.9 (6.5, 9.7) | 9.0 (6.3, 10.7) | 0.26 |
| Hours of cEEG, median (IQR) | 89.3 (79.7, 98.0) | 89.7 (77.9, 98.1) | 88.6 (80.5, 97.9) | 0.98 |
| Cannot determine (excess artifact at onset of recording) | 1 (0.7%) | 0 (0%) | 1 (1.5%) | |
| EEG seizures observed prior to 1st dose of study drug, n (%) | 30/140 (21%) | 18/79 (23%) | 12/61 (20%) | 0.66 |
SD standard deviation; BMI body mass index; IQR interquartile range; cEEG continuous video electroencephalogram
P values calculated using Chi-square tests for categorical variables and Wilcoxon rank sum tests for continuous variables.
Sentinel event = placental abruption, shoulder dystocia, uterine rupture, or prolapsed cord.
Lowest pH and worst base deficit among cord arterial, cord venous, and arterial blood gas samples taken before 60 minutes of age.
Severe encephalopathy as defined by modified Sarnat score.