Table 2.
Primary and Related Outcomes.
| Outcome | Hyperimmune Globulin (N = 203) | Placebo (N=191) |
|---|---|---|
| Primary outcome — no. (%)* | 46 (22.7) | 37 (19.4) |
| Fetus or neonate with CMV infection | 36 (17.7) | 32 (16.8) |
| Neonatal death without CMV infection | 0 | 0 |
| Fetal or neonatal death with proven CMV infection | 7 (3.4) | 3 (1.6) |
| Fetal death without proven CMV infection | 3 (1.5) | 2 (1.0) |
| CMV infection | ||
| None — no. (%) | 160 (78.8) | 156 (81.7) |
| Asymptomatic CMV infection — no. (%) | 20 (9.9) | 20 (10.5) |
| Symptomatic CMV infection — no. (%) | 23 (11.3) | 15 (7.9) |
| Jaundice | 3 | 1 |
| Hepatomegaly | 1 | 1 |
| Splenomegaly | 1 | 0 |
| Birth weight <5th percentile | 8 | 2 |
| Intracerebral calcifications | 1 | 0 |
| Head circumference <3rd percentile | 4 | 2 |
| Hypotonia | 1 | 1 |
| Seizures | 0 | 0 |
| Petechial rash | 1 | 5 |
| Hearing loss | 1 | 1 |
| Interstitial pneumonitis | 0 | 0 |
| Thrombocytopenia | 2 | 2 |
| Anemia | 2 | 1 |
| Hepatitis | 5 | 5 |
| Chorioretinitis | 0 | 0 |
*
For the primary outcome, the relative risk was 1.17 (95% confidence interval, 0.80 to 1.72; P = 0.42).