Table 3.
Other Neonatal Secondary Outcomes.*
| Outcome | Hyperimmune Globulin (N = 203) | Placebo (N = 191) | Difference | Relative Risk (95% CI) |
|---|---|---|---|---|
| All neonates | ||||
| Gestational age at delivery — wk | 38.2±4.1 | 38.6±3.6 | −0.41 (−1.17 to 0.35) | |
| Preterm birth at <37 wk gestation — no. (%) | 25 (12.3) | 16 (8.4) | 1.47 (0.81 to 2.67) | |
| Preterm birth at <34 wk gestation — no. (%) | 12 (5.9) | 7 (3.7) | 1.61 (0.65 to 4.01) | |
| Fetal or neonatal death — no. (%) | 10 (4.9) | 5 (2.6) | 1.88 (0.66 to 5.41) | |
| Termination of pregnancy — no. (%)† | 5 (2.5) | 2 (1.0) | 2.35 (0.47 to 21.95) | |
| Live-born infants | ||||
| Head circumference — cm | 33.9±2.1 | 34.1±1.9 | −0.25 (−0.66 to 0.15) | |
| Birth weight — g | 3268±657 | 3303±548 | −35 (−157 to 87) | |
| Birth weight <5th percentile — no./total no. (%) | 20/194 (10.3) | 10/186 (5.4) | 1.92 (0.92 to 3.99) | |
| Head circumference <3rd percentile — no./total no. (%) | 6/193 (3.1) | 5/186 (2.7) | 1.16 (0.36 to 3.72) | |
| Grade 3 or 4 intraventricular hemorrhage — no./total no. (%) | 1/193 (0.5) | 0/186 | ||
| Ventriculomegaly — no./total no. (%) | 1/194 (0.5) | 0/186 | ||
| Retinopathy of prematurity — no./total no. (%)† | 1/193 (0.5) | 1/186 (0.5) | 0.94 (0.03 to 31.5) | |
| Respiratory distress syndrome — no./total no. (%) | 5/193 (2.6) | 10/186 (5.4) | 0.48 (0.17 to 1.38) | |
| Chronic lung disease — no./total no. | 0/193 | 0/186 | ||
| Necrotizing enterocolitis (stage 2 or 3) — no./total no. | 0/193 | 0/186 | ||
| Hyperbilirubinemia — no./total no. (%) | 13/150 (8.7) | 19/138 (13.8) | 0.63 (0.32 to 1.23) | |
| Suspected sepsis — no./total no. (%) | 14/193 (7.3) | 16/186 (8.6) | 0.84 (0.42 to 1.68) | |
| Confirmed sepsis — no./total no. | 0/193 | 0/186 | ||
| Pneumonia — no./total no. (%)† | 1/193 (0.5) | 2/186 (1.1) | 0.47 (0.17 to 5.23) | |
| Seizures or encephalopathy — no./total no. | 0/193 | 0/186 | ||
| Median hospital stay (95% CI) — days | 2 (2 to 2) | 2 (2 to 2) | 0 | |
| Admission to intermediate or intensive care nursery | ||||
| Admission — no./total no. (%) | 33/193 (17.1) | 25/186 (13.4) | 1.27 (0.79 to 2.05) | |
| Median stay (95% CI) — days | 7 (4 to 12) | 5 (3 to 10) | 1 (−1 to 5) | |
*
Plus–minus values are means ±SD. Confidence intervals (CI) were not adjusted for multiplicity, so the intervals should not be used to infer definitive treatment effects.
†
Exact confidence intervals were calculated for rare outcomes with the use of StatXact software (Cytel).