Table 2. Primary and Secondary Outcomes.
| Outcome | No. (%) | Relative risk (95% CI)a | ||
|---|---|---|---|---|
| Betamethasone (n = 479) | Placebo (n = 470) | Unadjusted | Adjustedb | |
| Primary outcome | ||||
| DAS-II General Conceptual Ability <85c | 82 (17.1) | 87 (18.5) | 0.92 (0.70 to 1.22) | 0.94 (0.73 to 1.22) |
| Secondary outcomes | Mean difference (95% CI) | |||
| DAS-II General Conceptual Ability | 96.6 (13.8) | 96.6 (13.7) | 0.00 (−1.76 to 1.76) | 0.00 (−1.47 to 1.47) |
| Verbal ability | 97.7 (20.0) | 97.0 (19.7) | 0.69 (−1.85 to 3.22) | 0.59 (−1.61 to 2.79) |
| Nonverbal reasoning | 95.3 (4.9) | 96.3 (15.4) | −1.00 (−2.94 to 0.93) | −1.08 (−2.85 to 0.69) |
| Spatial ability | 98.2 (14.3) | 97.7 (14.4) | 0.46 (−1.37 to 2.29) | 0.64 (−1.00 to 2.28) |
| (n =522) | (n = 504) | Relative risk (95% CI) | ||
| Social Responsiveness Scale t score >65, No./total (%)d | 70/518 (13.5) | 72/504 (14.3) | 0.95 (0.70 to 1.28) | 0.92 (0.68 to 1.24) |
| >Level I Gross Motor Function Classification Systeme | 1 (0.2) | 1 (0.2) | ||
| Child Behavior Checklist t score f | Mean difference (95% CI) | |||
| Total problems | 48.5 (11.0) | 49.1 (11.2) | −0.58 (−1.94 to 0.78) | −0.81 (−2.15 to 0.52) |
| Normal | 433 (83.4) | 413 (81.9) | ||
| Borderline | 36 (6.9) | 44 (8.7) | ||
| Clinical | 50 (9.6) | 47 (9.3) | ||
| Median difference (95% CI) | ||||
| Internalizing behavior, median (IQR) | 48 (41 to 57) | 48 (43 to 57) | 0.00 (−1.45 to 1.45) | −0.61 (−1.97 to 0.75) |
| Normal | 422 (81.3) | 411 (81.5) | ||
| Borderline | 36 (6.9) | 39 (7.7) | ||
| Clinical | 61 (11.8) | 54 (10.7) | ||
| Externalizing behavior, median (IQR) | 48 (41 to 54) | 49 (41 to 57) | −1.00 (−2.88 to 0.88) | −0.60 (−2.00 to 0.80) |
| Normal | 438 (84.4) | 409 (81.2) | ||
| Borderline | 35 (6.7) | 39 (7.7) | ||
| Clinical | 46 (8.9) | 56 (11.1) | ||
| Dysregulation profile, median (IQR) | 156 (151 to 167) | 158 (151 to 171) | −1.00 (−3.34 to 1.34) | −0.68 (−2.05 to 0.68) |
| Anxious/depressed, median (IQR) | 51 (50 to 57) | 51 (50 to 57) | 0.00 (−0.22 to 0.22) | −0.27 (−0.52 to −0.03) |
| Normal | 473 (91.1) | 469 (93.1) | ||
| Borderline | 33 (6.4) | 21 (4.2) | ||
| Clinical | 13 (2.5) | 14 (2.8) | ||
| Attention problems, median (IQR) | 52 (50 to 57) | 52 (50 to 57) | 0.00 (−0.22 to 0.22) | 0.02 (−0.46 to 0.49) |
| Normal | 458 (88.2) | 450 (89.3) | ||
| Borderline | 42 (8.1) | 34 (6.7) | ||
| Clinical | 19 (3.7) | 20 (4.0) | ||
| Aggressive behavior, median (IQR) | 51 (50 to 56) | 51 (50 to 57) | 0.00 (0.00 to 0.00) | 0.00 (−0.27 to 0.27) |
| Normal | 479 (92.3) | 450 (89.3) | ||
| Borderline | 20 (3.9) | 29 (5.8) | ||
| Clinical | 20 (3.9) | 25 (5.0) | ||
Data are relative risk (95% CI) for categorical outcomes and mean difference (95% CI) or median difference (95% CI) for continuous outcomes.
Adjusted for maternal age, gestational age at delivery, child age, sex, maternal education, and center.
Differential Ability Scales 2nd Edition (DAS-II) General Conceptual Ability score has a mean (SD) of 100 (15); scores of 85 or higher are average and less than 85, below average, with higher scores indicating greater abilities.
Score range: less than 60, normal; 60 to 65, mild; 66 to 75, moderate; and 76 or higher, severe, with higher scores indicating greater problems.
There are 5 levels with greater functional impairment at increasing levels: walks without limitations, walks with limitations, walks with handheld mobility device, self-mobility with limitations; may use powered mobility, and transported in a manual wheelchair.
Score range: less than 60, normal; 60 to 63, borderline (84th-90th percentile); and 64 or higher, clinical (>90th percentile), with higher scores indicating greater problems. Values on syndrome scales (anxious or depressed, attention problems, and aggressive behavior) between the 93rd and 97th percentile are classified as borderline. Scores higher than the 97th percentile are clinical, indicating a potential need for referral. Values for internalizing behavior and externalizing behavior between the 84th and 90th percentile are classified as borderline. Scores higher than the 90th percentile are clinical. Child Behavior Checklist score is missing for 3 children.