Table 1. Characteristics of Children and Their Mothers at Midchildhood Assessment.
| Characteristic | FGR Group | Non-FGR Group | ||||
|---|---|---|---|---|---|---|
| Total | Repeated-Dose Betamethasone Treatment | Placebo | Total | Repeated-Dose Betamethasone Treatment | Placebo | |
| Maternal Characteristics | ||||||
| No. of mothers | 216 | 118 | 98 | 673 | 330 | 343 |
| Age, mean (SD), y | 31.9 (5.8)a | 31.5 (6.0) | 32.4 (5.4) | 30.4 (5.9) | 30.5 (5.9) | 30.4 (5.9) |
| Parity, No. (%) | ||||||
| 0 | 77 (35.6) | 43 (36.4) | 34 (34.7) | 207 (30.8) | 102 (30.9) | 105 (30.6) |
| 1-3 | 110 (50.9)a | 58 (49.2) | 52 (53.1) | 412 (61.2) | 204 (61.8) | 208 (60.6) |
| ≥4 | 29 (13.4)a | 17 (14.4) | 12 (12.2) | 54 (8.0) | 24 (7.3) | 30 (8.7) |
| Multiple pregnancy, No. (%) | 79 (36.6)a | 39 (33.1) | 40 (40.8) | 93 (13.8) | 48 (14.5) | 45 (13.1) |
| Smoking during pregnancy, No. (%) | 58 (26.9) | 36 (30.5) | 22 (22.4) | 210 (31.2) | 97 (29.4) | 113 (32.9) |
| Gestational age at trial entry, mean (SD), wk | 28.5 (2.1) | 28.5 (2.1) | 28.5 (2.1) | 28.3 (2.2) | 28.3 (2.3) | 28.4 (2.2) |
| Main reasons for risk of preterm birth, No. (%)b | ||||||
| Preterm prelabor rupture of membranes, No. (%) | 35 (16.2)a | 19 (16.1) | 16 (16.3) | 248 (36.8) | 108 (32.7)c | 140 (40.8) |
| Preterm labor | 34 (15.7)a | 23 (19.5) | 11 (11.2) | 192 (28.5) | 98 (29.7) | 94 (27.4) |
| Severe FGR | 46 (21.3)a | 26 (22.0) | 20 (20.4) | NA | NA | NA |
| Preeclampsia | 67 (31.0)a | 32 (27.1) | 35 (35.7) | 27 (4.0) | 16 (4.8) | 11 (3.2) |
| Cervical incompetence | 11 (5.1)a | 5 (4.2) | 6 (6.1) | 67 (10.0) | 38 (11.5) | 29 (8.4) |
| Antepartum hemorrhage | 34 (15.7)a | 20 (16.9) | 14 (14.3) | 218 (32.4) | 118 (35.8) | 100 (29.2) |
| Multiple pregnancy | 13 (6.0) | 6 (5.1) | 7 (7.1) | 21 (3.1) | 14 (4.2) | 7 (2.0) |
| Other | 63 (29.2)a | 34 (28.8) | 29 (29.6) | 96 (14.3) | 44 (13.3) | 52 (15.2) |
| No. of trial treatments, No. (%) | ||||||
| 1 | 92 (42.6) | 47 (39.8) | 45 (45.9) | 274 (40.7) | 130 (39.4) | 144 (42.0) |
| 2-3 | 72 (33.3) | 33 (28.0) | 39 (39.8) | 245 (36.4) | 118 (35.8) | 127 (37.0) |
| ≥4 | 52 (24.1) | 38 (32.2)c | 14 (14.3) | 154 (22.9) | 82 (24.8) | 72 (21.0) |
| Speak only English at home, No. (%) | 177 (81.9)a | 96 (81.4) | 81 (82.6) | 594 (88.3) | 293 (88.8) | 301 (87.8) |
| Intact family, No. (%) | 146 (67.6) | 80 (67.8) | 66 (67.3) | 413 (61.4) | 196 (59.4) | 217 (63.3) |
| Occupation home duties only, No. (%) | 66 (30.6) | 41 (34.7) | 25 (25.5) | 186 (27.6) | 87 (26.4) | 99 (28.9) |
| Neonatal Characteristics | ||||||
| No. of infants | 261 | 139 | 122 | 727 | 354 | 373 |
| Female, No. (%) | 126 (48.3) | 74 (53.2) | 52 (42.6) | 319 (43.9) | 144 (40.7) | 175 (46.9) |
| Gestational age at birth, mean (SD), wk | 31.8 (3.1)a | 32.2 (3.2)c | 31.2 (3.0) | 32.9 (4.0) | 32.9 (4.1) | 33 (3.9) |
| Birth weight, mean (SD), g | 1407 (525)a | 1476 (519)c | 1328 (521) | 2095 (830) | 2090 (867) | 2100 (795) |
| Birth weight z score, mean (SD) | −1.2 (0.8)a | −1.3 (0.8) | −1.2 (0.8) | 0.1 (0.7) | 0.1 (0.8) | 0.2 (0.7) |
| Head circumference z score, mean (SD) | −0.9 (0.9)a | −0.9 (1.0) | −0.9 (0.9) | 0.2 (1.1) | 0.1 (1.1) | 0.2 (1.0) |
| Respiratory distress syndrome, No. (%)d | 106 (40.6) | 43 (30.9)c | 63 (51.6) | 245 (33.7) | 107 (30.2) | 138 (37.0) |
| Severity of neonatal lung disease, No. (%)e | c | c | ||||
| Severe | 40 (15.3) | 11 (7.9) | 29 (23.8) | 85 (11.7) | 29 (8.2) | 56 (15.0) |
| Moderate | 43 (16.5) | 22 (15.8) | 21 (17.2) | 130 (17.9) | 58 (16.4) | 72 (19.3) |
| Mild | 90 (34.5) | 43 (30.9) | 47 (38.5) | 217 (29.8) | 119 (33.6) | 98 (26.3) |
| None | 88 (33.7) | 63 (45.3) | 25 (20.5) | 295 (40.6) | 148 (41.8) | 147 (39.4) |
| Mechanical ventilation, No. (%) | 154 (59.0)a | 67 (48.2)c | 87 (71.3) | 344 (47.3) | 163 (46.0) | 181 (48.5) |
| Oxygen therapy, No. (%) | 159 (60.9) | 73 (52.5)c | 86 (70.5) | 407 (56.0) | 190 (53.7) | 217 (58.2) |
| Surfactant, No. (%) | 76 (29.1) | 26 (18.7)c | 50 (41.0) | 182 (25.0) | 81 (22.9) | 101 (27.1) |
| Serious neonatal morbidity, No. (%)f | 78 (29.9)a | 31 (22.3)c | 47 (38.5) | 132 (18.2) | 57 (16.1) | 75 (20.1) |
Abbreviations: FGR, fetal growth restriction; NA, not applicable.
P < .05 for comparison between subgroups (Fisher exact test or unpaired, 2-tailed t test).
Indicates at trial entry; categories are not mutually exclusive.
P < .05 for comparison between trial intervention groups within subgroup (Fisher exact test or t test).
Indicates clinical signs of respiratory distress syndrome and a ground-glass appearance on chest radiograph.
Mild indicates mean airway pressure (MAP) of less than 7 cm or fractional inspired oxygen (Fio2) of less than 0.40; moderate, MAP of 7 to less than 10 cm H2O or Fio2 0.40 to 0.79; and severe, MAP of at least 10 cm or Fio2 of at least 0.80.
Indicates air leak syndrome, patent ductus arteriosus, need for oxygen therapy at 36 weeks’ postmenstrual age, severe intraventricular hemorrhage (grade 3 or 4), periventricular leukomalacia, proven necrotizing enterocolitis, and/or retinopathy of prematurity.