Table 1.
Outcomes among Children at 24 Months.*
| Outcome | Hyperimmune Globulin | Placebo | Relative Risk or Difference (95% CI)† |
|---|---|---|---|
| Composite outcome: death or CMV infection with severe disability — no./total no. (%) | 20/149 (13.4) | 15/149 (10.1) | 1.33 (0.71 to 2.50) |
| Death or fetal loss‡ | 10/184 (5.4) | 5/176 (2.8) | — |
| Sensorineural hearing loss, unilateral or bilateral | 2/138 (1.4) | 7/146 (4.8) | — |
| Chorioretinitis | 0/173 (0) | 1/171 (0.6) | — |
| Seizure disorder | 2/173 (1.2) | 0/171 (0) | — |
| Bayley-III cognitive score of <70 | 4/155 (2.6) | 4/160 (2.5) | — |
| Bayley-III motor score of <70 | 6/155 (3.9) | 1/158 (0.6) | — |
| Overall status — no./total no. (%) | |||
| Death or fetal loss§ | 10/148 (6.8) | 5/149 (3.4) | — |
| Congenital CMV infection with severe disability | 6/148 (4.1) | 7/149 (4.7) | — |
| Congenital CMV infection without severe disability | 21/148 (14.2) | 19/149 (12.8) | — |
| Not infected with CMV with severe disability | 4/148 (2.7) | 3/149 (2.0) | — |
| Not infected with CMV with no disabilities | 107/148 (72.3) | 115/149 (77.2) | — |
| Other outcomes | |||
| Bayley-III cognitive score | 96.2±15.1 | 97.1±13.5 | −0.9 (−4.1 to 2.3) |
| Bayley-III motor score | 98.7±16.4 | 101.9±14.9 | −3.2 (−6.7 to 0.3) |
| Birth weight <10th percentile — no./total no. (%) | 20/169 (11.8) | 21/167 (12.6) | 0.94 (0.53 to 1.67) |
Plus–minus data are means ±SD. Severe disability was defined as any sensorineural hearing loss, developmental delay (a cognitive or motor score of less than 70 on the Bayley Scales of Infant and Toddler Development, third edition [Bayley-III], which is >2 SD below the standardized mean score of 100; higher scores on the scale indicate better performance), chorioretinitis, or seizure disorder.
Relative risk is provided for the composite outcome and for <10th percentile weight, and the between-group difference is provided for the mean Bayley-III scores. The widths of the confidence intervals have not been adjusted for multiplicity and should not be used for hypothesis testing.
No deaths occurred after the delivery hospitalization.
Data from the cohort of participants with information on death or fetal loss plus information on CMV infection and disability status are included here.