Table 1.
Characteristic | Erythropoietin (N = 257) | Placebo (N = 243) |
---|---|---|
| ||
Maternal characteristics | ||
Race — no. (%)† | ||
White | 183 (71.2) | 173 (71.2) |
Black | 28 (10.9) | 38 (15.6) |
Asian | 18 (7.0) | 15 (6.2) |
Other | 28 (10.9) | 17 (7.0) |
Hispanic ethnic group — no. (%)† | 63 (24.5) | 59 (24.3) |
Age — yr | 29.6±6.3 | 30.0±6.6 |
Education, high school or less — no. (%) | 102 (39.7) | 83 (34.2) |
Parity of 1, including trial infant — no. (%) | 145 (56.4) | 141 (58.0) |
Pregnancy and delivery complications — no. (%) | ||
Maternal chorioamnionitis or fever | 45 (17.5) | 32 (13.2) |
Maternal preeclampsia or eclampsia | 22 (8.6) | 23 (9.5) |
Gestational diabetes | 33 (12.8) | 25 (10.3) |
Maternal obesity: body-mass index >30‡ | 47 (18.3) | 42 (17.3) |
Sentinel event§ | 71 (27.6) | 72 (29.6) |
Shoulder dystocia | 14 (5.4) | 18 (7.4) |
Placental abruption | 40 (15.6) | 31 (12.8) |
Prolapsed cord | 10 (3.9) | 13 (5.3) |
Uterine rupture | 13 (5.1) | 11 (4.5) |
Cesarean section delivery | 170 (66.1) | 159 (65.4) |
Outborn delivery | 214 (83.3) | 201 (82.7) |
Infant characteristics | ||
Female sex — no. (%) | 122 (47.5) | 103 (42.4) |
Birth weight — g | 3332±572 | 3414±614 |
Gestational age — wk | 39.1±1.4 | 39.2±1.5 |
Median 5-min Apgar score (IQR) | 3 (2–5) | 3 (2–5) |
Median 10-min Apgar score (IQR) | 5 (3–7) | 5 (3.8–6) |
Continued resuscitation at 10 min — no. (%)¶ | 243 (94.6) | 217 (89.3) |
Lowest pH‖ | 6.95±0.17 | 6.91±0.17 |
Worst base deficit‖ | 18.0±6.0 | 18.5±6.8 |
Severe encephalopathy — no. (%)** | 59 (23.0) | 54 (22.2) |
Median age at randomization — hr (IQR) | 14 (10–19) | 14 (10–20) |
Age at first treatment — hr | 17.6±5.5 | 17.6±5.5 |
Plus–minus values are means ±SD. IQR denotes interquartile range.
Race and ethnic group were reported by the mother or father.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
A sentinel event was defined as shoulder dystocia, placental abruption, prolapsed cord, or uterine rupture.
Ongoing resuscitation with chest compressions, mechanical ventilation, or both was warranted at 10 minutes of age.
Shown is the lowest pH or worst base deficit among cord arterial, cord venous, and arterial blood gas samples obtained tained before 60 minutes of age.
Severe encephalopathy was defined according to Sarnat criteria (Table S1 in the Supplementary Appendix).