Table 4.
Adverse Outcome per Study Arm
Placebo | Iodine | Bolus 4 μg/kg | Continuous 4 μg/kg | Bolus 8 μg/kg | Continuous 8 μg/kg | Bolus 16 μg/kg | Continuous 16 μg/kg | Total group | |
---|---|---|---|---|---|---|---|---|---|
Total in study, n | 28 | 25 | 24 | 27 | 20 | 27 | 7 | 8 | 166 |
3 year follow-up not done, n | 10 | 7 | 12 | 5 | 3 | 6 | 1 | 1 | 45 |
3 year outcome known, n | 18 | 18 | 12 | 22 | 17 | 21 | 6 | 7 | 121 |
Outcome at age 3 years | |||||||||
Neonatal death, n | 5 | 4 | 2 | 4 | 6 | 6 | 3 | 2 | 32 |
Abnormal development, n | 1 | 2 | 0 | 2 | 2 | 1 | 0 | 0 | 8 |
Death or abnormal development*, % | 33% | 33% | 17% | 27% | 47% | 33% | 50% | 29% | 33% |
Abnormal development: moderate or severe cognitive delay in development and/or cerebral paresis and Gross Motor Function Classification System ≥2.