Table 2. Fetal or Neonatal Outcomes (Intention-to-Treat Analysis)a.
| Outcome | No./total No. (%) | RR (95% CI) | Mean difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Sildenafil | Placebo | ||||
| Primary outcomeb | 65/108 (60.2) | 58/107 (54.2) | 1.11 (0.88 to 1.40) | NA | .38 |
| Birth weight, mean (SD), g | 829 (537) | 884 (627) | NA | −55 (−211 to 101) | .49 |
| Stillbirth | 23/108 (21.3) | 29/107 (27.1) | 0.79 (0.49 to 1.27) | NA | .32 |
| Birth weight, mean (SD), g | 414 (143) | 362 (115) | NA | 53 (−17 to 123) | .15 |
| Percentilec | |||||
| <Tenth | 10/13 (76.9) | 11/11 (100) | 0.77 (0.57 to 1.04) | NA | .08 |
| <Third | 8/13 (61.5) | 10/11 (90.9) | 0.68 (0.42 to 1.08) | NA | .10 |
| Live birth | 85/108 (78.7) | 78/107 (72.9) | 1.08 (0.93 to 1.26) | NA | .32 |
| Birth weight, mean (SD), g | 942 (549) | 1078 (628) | NA | −136 (−318 to 44) | .14 |
| Percentilec | |||||
| <Tenth | 33/73 (45.2) | 30/68 (44.1) | 1.02 (0.71 to 1.48) | NA | .90 |
| <Third | 20/73 (27.4) | 19/68 (27.9) | 0.98 (0.57 to 1.67) | NA | .94 |
| Apgar score 5 min <7 | 32/108 (37.6) | 25/107 (32.1) | 1.17 (0.77 to 1.79) | NA | .46 |
| Cord blood gas pH <7.10 | 2/48 (4.2) | 0/31 (0) | |||
| Neonatal death | 21/85 (24.7) | 11/78 (14.1) | 1.75 (0.9 to 3.39) | NA | .10 |
| Survival | |||||
| At hospital discharge | 64/85 (75.3) | 67/78 (85.9) | 0.88 (0.75 to 1.02) | NA | .09 |
| With major morbidity at hospital discharge | 21/85 (24.7) | 18/78 (23.1) | 1.07 (0.62 to 1.85) | NA | .81 |
| Without major morbidity at hospital discharge | 43/85 (50.6) | 49/78 (62.8) | 0.81 (0.61 to 1.06) | NA | .12 |
| Postmenstrual age at first discharge home, mean (SD), wk | 42 (7.9) | 40 (2.3) | NA | 2.04 (0.04 to 4.03) | .047 |
| IVH grade III or IV | 3/85 (3.5) | 2/78 (2.6) | 1.38 (0.24 to 8.02) | NA | .72 |
| PVL grade II or more | 0/85 (0) | 0/78 (0) | NA | >.99 | |
| BPD | |||||
| Moderate or severe | 23/85 (27.1) | 16/78 (20.5) | 1.32 (0.75 to 2.31) | NA | .33 |
| None | 41/85 (48.2) | 47/78 (60.3) | 0.80 (0.61 to 1.06) | NA | .13 |
| ROP treated by laser or surgery | 8/85 (9.5) | 3/78 (3.8) | 2.45 (0.67 to 8.9) | NA | .17 |
| 1 or more culture-proven episode of infection or clinical episode of infection with antibiotic treatment necessary ≥5 d | 44/85 (51.8) | 35/78 (44.9) | 1.15 (0.84 to 1.59) | NA | .38 |
| NEC grade II or more | 7/85 (8.3) | 8/78 (10.3) | 0.80 (0.31 to 2.11) | NA | .66 |
| Abdominal circumference, initial growth rate between randomization and 14 d, mean (SD), mm/wk | 7.4 (6.2) | 8.8 (7.3) | NA | −1.4 (−3.43 to 0.69) | .19 |
Abbreviations: BPD, bronchopulmonary dysplasia; EFW, estimated fetal weight; IVH, intraventricular hemorrhage; NA, not applicable; NEC, necrotizing enterocolitis; PVL, periventricular leukomalacia; ROP, retinopathy of prematurity; RR, relative risk.
a
Intention-to-treat analysis corrected for gestational age and EFW at randomization, and per-protocol analysis had similar results.
b
The primary outcome was perinatal death or major neonatal morbidity before discharge.
c
Birth weight percentiles were only calculated for infants born after 23 weeks gestational age.