Table 2. Primary and Secondary Outcomes.
| Outcome | Total (n = 142) | Gestational age | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 23-26 wk (n = 80) | 27-30 wk (n = 62) | ||||||||
| Nonintervention (n = 72) | Ibuprofen (n = 70) | P value | Nonintervention (n = 42) | Ibuprofen (n = 38) | P value | Nonintervention (n = 30) | Ibuprofen (n = 32) | P value | |
| Primary outcome | |||||||||
| BPD or death | 32 (44) | 35 (50) | .51 | 26 (62) | 25 (66) | .72 | 6 (20) | 10 (31) | .31 |
| Secondary outcomes | |||||||||
| Major morbidity/mortality, No. (%) | |||||||||
| BPD | 27/67 (40) | 29/64 (45) | .56 | 21/37 (57) | 21/34 (62) | .67 | 6 (20) | 8/30 (27) | .54 |
| Death before discharge | 6 (8) | 6 (9) | .96 | 6 (14) | 4 (11) | .74 | 0 | 2 (6) | .49 |
| IVH (grade ≥III) | 4 (6) | 2 (3) | .68 | 3 (7) | 1 (3) | .62 | 1 (3) | 1 (3) | >.99 |
| ROP (stage ≥3) | 14 (19) | 15 (21) | .77 | 13 (31) | 14 (37) | .58 | 1 (3) | 1 (3) | >.99 |
| NEC (stage ≥IIb) | 3 (4) | 7 (10) | .21 | 3 (7) | 4 (11) | .70 | 0 | 3 (9) | .12 |
| Gastrointestinal surgery | 6 (8) | 9 (13) | .38 | 6 (14) | 5 (13) | .88 | 0 | 4 (13) | .11 |
| Sepsis | 4 (6) | 10 (14) | .08 | 4 (10) | 9 (24) | .09 | 0 | 1 (3) | .49 |
| Oxygen or ventilator dependency until hospital discharge, (IQR), d | |||||||||
| Ventilator support | 19 (2-31) | 17 (1-36) | .76 | 25 (18-39) | 28 (6-48) | .87 | 2 (0-18) | 3 (0-18) | .66 |
| N-CPAP/HFNC | 58 (28-72) | 51 (26-73) | .60 | 71 (66-75) | 73 (51-80) | .90 | 26 (12-46) | 27 (9-45) | .70 |
| Supplemental oxygen | 22 (8-41) | 24 (6-34) | .54 | 36 (17-43) | 30 (24-40) | .91 | 18 (3-26) | 8.5 (1-23) | .25 |
| PDA-related outcomes, No. (%) | |||||||||
| Surgical ligation | 0 | 1 (1) | 0 | 1 (3) | 0 | 0 | |||
| Backup oral ibuprofen treatment | 0 | 1 (1) | 0 | 0 | 0 | 1 (3) | |||
| NT-proBNP 2 wk after randomization, mean (SD), pg/mL | 13 812 (13 468) | 11 552 (11 480) | .43 | 19 206 (13 384) | 16 361 (11 040) | .50 | 6800 (10 028) | 5813 (9249) | .53 |
| Ductal closure, No. (%) | |||||||||
| 1 wk After randomization | 3 (4) | 14 (20) | .003 | 1 (2) | 3 (8) | .34 | 2 (7) | 11 (34) | .007 |
| At 36 wk PMA | 50 (69) | 51 (73) | .49 | 30 (71) | 27 (71) | .86 | 20 (67) | 24 (75) | .2 |
| Before hospital discharge | 59 (82) | 62 (89) | .27 | 38 (90) | 34 (89) | >.99 | 21 (70) | 6 (81) | .12 |
| Transcatheter PDA occlusion at OPD | 4 (6) | 2 (3) | .40 | 1 (2) | 1 (3) | .97 | 3 (10) | 1 (3) | .27 |
| Other outcomes | |||||||||
| Full enteral feeding (>120 mL/kg/d), mean (SD), d | 26.3 (14.4) | 29.2 (16.3) | .39 | 32.0 (13.3) | 36.1 (16.0) | .27 | 20.1 (13.1) | 21.0 (12.6) | .78 |
| Oliguric renal failure, No. (%)a | 6 (8) | 8 (11) | .54 | 6 (14) | 7 (18) | .62 | 0 | 1 (3) | .33 |
| Nonoliguric renal dysfunction, No. (%)b | 9 (13) | 15 (21) | .16 | 6 (14) | 9 (24) | .28 | 2 (7) | 7 (22) | .09 |
| Highest serum creatinine after randomization, mean (SD), mg/dL | 1.2 (0.9) | 1.0 (0.4) | .95 | 1.5 (1.1) | 1.2 (0.4) | .75 | 0.8 (0.4) | 0.8 (0.3) | .38 |
| Body weight at 36 wk PMA, mean (SD), g | 1949 (360) | 1894 (418) | .42 | 1885 (312) | 1815 (380) | .40 | 2028 (403) | 1986 (447) | .71 |
Abbreviations: BPD, bronchopulmonary dysplasia; HFNC, high-flow nasal cannula; IQR, interquartile range; IVH, intraventricular hemorrhage; N-CPAP, nasal continuous positive airway pressure; NEC, necrotizing enterocolitis; NT-proBNP, N-terminal probrain natriuretic peptide; OPD, outpatient department; PDA, patent ductus arteriosus; PMA, postmenstrual age; ROP, retinopathy of prematurity.
SI conversion factor: To convert serum creatinine to millimoles per liter, multiply by 88.4.
a
Urine output less than 0.5 mL/kg/d for more than 24 hours combined with serum creatinine level greater than or equal to 2.0 mg/dL.
b
Serum creatinine level greater than or equal to 2.0 mg/dL without oliguria.