Table 4. Prespecified Sensitivity and Subgroup Analyses on the Primary Outcome According to Treatment.
| Analysis | No./total No. (%) | RR (95% CI) | P valuea | |
|---|---|---|---|---|
| Sildenafil | Placebo | |||
| Sensitivity | ||||
| Per protocol | 60/103 (58.3) | 54/100 (54.0) | 1.08 (0.85-1.38) | .54 |
| Adjusted for EFW and GA at randomization | 65/108 (60.2) | 58/107 (54.2) | 1.23 (0.69-2.23) | .48 |
| Post hoc adjustment for sex | 65/108 (60.2) | 58/107 (54.2) | 1.33 (0.77-2.30) | .31 |
| Excluding | ||||
| Neonates who appeared to have a congenital anomaly | 60/102 (58.8) | 54/101 (53.5) | 1.10 (0.86-1.40) | .44 |
| Participants who were pregnant or for whom the neonate was admitted at NICU when trial was stopped (post hoc) | 60/97 (61.9) | 55/98 (56.1) | 1.10 (0.87-1.39) | .42 |
| Placental growth factor, percentile of the reference value | ||||
| <Fifth | 36/56 (64.3) | 25/53 (47.2) | 1.36 (0.96-1.93) | .99 |
| ≥Fifth | 4/5 (80.0) | 3/6 (50.0) | 1.60 (0.64-3.98) | |
| GA at randomization, wk | ||||
| <25 | 42/60 (70.0) | 36/54 (66.7) | 1.05 (0.82-1.35) | .85 |
| ≥25 | 23/48 (47.9) | 22/53 (41.5) | 1.15 (0.75-1.78) | |
| EFW at randomization, g | ||||
| <300 | 15/19 (78.9) | 21/26 (80.8) | 0.98 (0.73-1.32) | .70 |
| 300-599 | 44/67 (65.7) | 23/48 (47.9) | 1.37 (0.97-1.93) | |
| ≥600 | 3/18 (16.7) | 10/26 (38.5) | 0.43 (0.14-1.36) | |
Abbreviations: EFW, estimated fetal weight; GA, gestational age; NICU, neonatal intensive care unit; RR, relative risk.
a
The P value is from the interaction term for subgroup analyses and from the treatment effect for the sensitivity analyses.