Neurodevelopmental Follow-up of Dexamethasone RCTs Reported After 2001
| Study, Planned Age at Follow-up . | Follow-up, % (No. of Infants Seen) . | Treatment Start Time . | Dexamethasone Dosing Regimen . | Primary Neurodevelopmental Findings . |
|---|---|---|---|---|
| McEvoy et al,17 1 y | 66 (39) | At 7–21 d | High vs low dose: 7-d taper from 0.5 mg/kg per d vs 0.2 mg/kg per d | MDI < 70: 24% (high) vs 17% (low) (NS); CP: 10% vs 11%(NS) |
| Armstrong et al,24 18 mo chronological age | 96 (64) | On day 7 | 42-d taper vs 3-d pulse | No difference in 18-mo outcomes |
| No disability: 34% vs 31%(NS) | ||||
| Doyle et al,25 2 y corrected age | 98 (58) | After 7 d | 0.15 mg/kg per d tapered over 10 d | Death or major disability: 46% vs 43% (NS); death or CP: 23% vs 37% (NS); CP: 14% vs 22% (NS); major disability 41% vs 31%(NS) |
| Stark et al,26 18–22 mo corrected age | 74 (123) | On day 1 | 0.15 mg/kg per d tapered over 7 d | MDI < 70: 51% vs 43% (NS); PDI < 70: 30% vs 35%(NS); abnormal neurologic exam: 25% each group |
| Romagnoli et al,27 3 y | 100 (30) | On day 4 | 0.5 mg/kg per d tapered over 1 wk | No differences in any parameter; CP: 9% vs 14%(NS) |
| Wilson et al,28 7 y | 84 (127) | Before 3 d | 4 groups: 0.5 mg/kg per d tapered over 12 d vs late(15 d) selective, vs inhaled early or late selective | No difference in cognitive, behavioral, CP, or combined outcomes |
| Yeh et al,29 school age (mean: 8 y) | 92 (146) | On day 1 | 0.5 mg/kg per d for 1 wk, then tapered for a total of 28 d | Treated children were shorter(P = .03), had smaller head circumference (P = .04), lower IQ scores (P = .008), and more significant disabilities (CP, IQ < 5th percentile, vision or hearing impairment): 39% vs 22% (P = .04) |
| O'Shea et al,30 4–11 y | 89 (84) | On day 15–25 | 0.5 mg/kg per d tapered over 42 d vs placebo | Death or major NDIa: 47% vs 41% (NS); major NDI alone: 36% vs 14% (P = .01) |
| Gross et al,31 15 y | 100 (22) | On day 14 | 0.5 mg/kg per d tapered over 42 d vs 18-d taper vs placebo | Intact survival (IQ > 70, normal neurologic exam, regular classroom): 69% vs 25% (18-d course) vs 18% (placebo)(P < .05) |
| Jones and the Collaborative Dexamethasone Trial Follow-up Group,32 13–17 y | 95 (150) | At 2–12 wk | 0.5 mg/kg per d for 7 d | No difference in moderate/severe disability (defined as IQ > 2 SDs < mean, CP, hearing or vision loss); CP: 24% vs 15%(relative risk: 1.58 [95% confidence interval: 0.81–3.07]) |
| Study, Planned Age at Follow-up . | Follow-up, % (No. of Infants Seen) . | Treatment Start Time . | Dexamethasone Dosing Regimen . | Primary Neurodevelopmental Findings . |
|---|---|---|---|---|
| McEvoy et al,17 1 y | 66 (39) | At 7–21 d | High vs low dose: 7-d taper from 0.5 mg/kg per d vs 0.2 mg/kg per d | MDI < 70: 24% (high) vs 17% (low) (NS); CP: 10% vs 11%(NS) |
| Armstrong et al,24 18 mo chronological age | 96 (64) | On day 7 | 42-d taper vs 3-d pulse | No difference in 18-mo outcomes |
| No disability: 34% vs 31%(NS) | ||||
| Doyle et al,25 2 y corrected age | 98 (58) | After 7 d | 0.15 mg/kg per d tapered over 10 d | Death or major disability: 46% vs 43% (NS); death or CP: 23% vs 37% (NS); CP: 14% vs 22% (NS); major disability 41% vs 31%(NS) |
| Stark et al,26 18–22 mo corrected age | 74 (123) | On day 1 | 0.15 mg/kg per d tapered over 7 d | MDI < 70: 51% vs 43% (NS); PDI < 70: 30% vs 35%(NS); abnormal neurologic exam: 25% each group |
| Romagnoli et al,27 3 y | 100 (30) | On day 4 | 0.5 mg/kg per d tapered over 1 wk | No differences in any parameter; CP: 9% vs 14%(NS) |
| Wilson et al,28 7 y | 84 (127) | Before 3 d | 4 groups: 0.5 mg/kg per d tapered over 12 d vs late(15 d) selective, vs inhaled early or late selective | No difference in cognitive, behavioral, CP, or combined outcomes |
| Yeh et al,29 school age (mean: 8 y) | 92 (146) | On day 1 | 0.5 mg/kg per d for 1 wk, then tapered for a total of 28 d | Treated children were shorter(P = .03), had smaller head circumference (P = .04), lower IQ scores (P = .008), and more significant disabilities (CP, IQ < 5th percentile, vision or hearing impairment): 39% vs 22% (P = .04) |
| O'Shea et al,30 4–11 y | 89 (84) | On day 15–25 | 0.5 mg/kg per d tapered over 42 d vs placebo | Death or major NDIa: 47% vs 41% (NS); major NDI alone: 36% vs 14% (P = .01) |
| Gross et al,31 15 y | 100 (22) | On day 14 | 0.5 mg/kg per d tapered over 42 d vs 18-d taper vs placebo | Intact survival (IQ > 70, normal neurologic exam, regular classroom): 69% vs 25% (18-d course) vs 18% (placebo)(P < .05) |
| Jones and the Collaborative Dexamethasone Trial Follow-up Group,32 13–17 y | 95 (150) | At 2–12 wk | 0.5 mg/kg per d for 7 d | No difference in moderate/severe disability (defined as IQ > 2 SDs < mean, CP, hearing or vision loss); CP: 24% vs 15%(relative risk: 1.58 [95% confidence interval: 0.81–3.07]) |
MDI indicates Bayley Mental Developmental Index; NS, not significant. PDI, Bayley Psychomotor Development Index; NDI, neurodevelopmental impairment.
Major neurodevelopmental impairment included CP and/or an IQ score of <70.