Table 3.
Baseline characteristics of patients and clinical outcomes comparison by “per protocol” analysis.
| Control arm N = 38 | Intervention arm N = 17 | P | SMD | |
|---|---|---|---|---|
| Gestational age, weeks | 25·9 (24·8–26·9) | 26·1 (24·7–27·0) | 0·883 | 0·012 |
| Weight, g | 705 (600–783) | 775 (675–947) | 0·023 | 0·782 |
| Male/female, % | 23 (60·5)/15 (39·5) | 8 (47·1)/9 (52·9) | 0·384 | 0·273 |
| Twins | 9 (23·7) | 2 (11·8) | 0·473 | 0·316 |
| IUGR | 10 (6·3) | 0 | 0·023 | 0·845 |
| Apgar score 1 min | 5 (4–7) | 6 (4–7) | 0·984 | 0·013 |
| Apgar score 5 min | 8 (7–8) | 8 (7–8) | 0·985 | 0·100 |
| CRIB II score | 12·0 (10·0–13·5) | 11·0 (10·0–13·0) | 0·395 | 0·211 |
| Hb at birth, g/dL | 14·7 (13·7–16·4) | 15·0 (23·8–16·6) | 0·628 | 0·123 |
| Age at first transfusion, PMA week | 27·4 (26·0–28·5) | 27·7 (26·0–29·1) | 0·449 | 0·157 |
| Total RBC units (40 weeks PMA) | 4·0 (2·7–6·0) | 3·0 (2·0–5·5) | 0·357 | 0·207 |
| A-RBC units | 4·0 (2·7–6·0) | 1·0 (0·0–1·5) | <0·001 | 2·112 |
| CB-RBC units | 0·0 (0·0–0·0) | 2·0 (1·0–4·5) | <0·001 | 2·000 |
| Total RBC units (<30 weeks PMA) | 2·0 (1·0–4·0) | 2·0 (1·0–3·5) | 0·251 | 0·224 |
| A-RBC units | 2·0 (1·0–4·0) | 0·0 (0·0–0·0) | <0·001 | 2·186 |
| CB-RBC units | 0·0 (0·0–0·0) | 2·0 (1·0–3·5) | <0·001 | 1·704 |
| Patients with PLT transfusions (%) | 6 (15·7) | 4 (23·5) | 0·479 | 0·200 |
| Hyaline membrane disease | 26 (68·4) | 16 (94·1) | 0·045 | 0·605 |
| ROP (any stage) | 27 (71·1) | 12 (70·6) | 0·999 | 0·010 |
| Stage 1 | 4 (10·5) | 3 (17·6) | 0·663 | 0·213 |
| Stage 2 | 12 (31·6) | 9 (52·9) | 0·148 | 0·439 |
| Stage 3 | 11 (28·9) | 0 (0·0) | 0·011 | 0·903 |
| Plus disease | 8 (21·1) | 0 (0·0) | 0·047 | 0·730 |
| Severe ROP | 13 (34·2) | 0 (0·0) | 0·005 | 1·020 |
| Treated ROP | 10 (26·3) | 0 (0·0) | 0·022 | 0·845 |
| Sepsis (suspected) | 30 (78·9) | 14 (82·4) | 0·999 | 0·086 |
| Sepsis (documented) | 30 (78·9) | 9 (52·9) | 0·061 | 0·571 |
| IVH (any stages) | 18 (46·2) | 8 (47·1) | 0·810 | 0·100 |
| IVH Stage 1/2 | 11 (28·9) | 4 (23·5) | 0·910 | 0·122 |
| IVH Stage 3/4 | 6 (15·4) | 4 (23·5) | 0·196 | |
| BPD (any stage) | 29 (76·3) | 12 (70·6) | 0·741 | 0·130 |
| Moderate or Severe BPD | 24 (63·2) | 5 (29·4) | 0·039 | 0·719 |
| PDA | 19 (20·0) | 10 (58·8) | 0·568 | 0·178 |
| Pulmonary hypertension | 7 (18·4) | 0 (0·0) | 0·086 | 0·552 |
| NEC | 4 (10·5) | 2 (11·8) | 0·949 | 0·039 |
| Antibiotic therapy (days) | 26 (16–46) | 23 (17–32) | 0·422 | 0·354 |
| Antifungal therapy (days) | 16 (11–24) | 11 (9–41) | 0·868 | 0·304 |
| Inotropic drugs (%) | 11 (28·9) | 7 (41·2) | 0·534 | 0·258 |
| Inotropic drugs (days) | 4 (1–7) | 2 (2–4) | 0·512 | 0·161 |
| Invasive ventilation (%) | 25 (65·8) | 12 (70·6) | 0·766 | 0·103 |
| Invasive ventilation (days) | 6 (0–21) | 4 (0–21) | 0·742 | 0·742 |
| Oxygen therapy (days) | 44 (20–75) | 32 (5–59) | 0·171 | 0·409 |
| Steroid therapy (%) | 24 (63·2) | 8 (57·1) | 0·375 | 0·328 |
| Erythropoietin (%) | 18 (47·4) | 4 (23·5) | 0·143 | 0·515 |
| Surfactant (%) | 30 (78·9) | 14 (82·4) | 0·999 | 0·086 |
| Caffeine (%) | 35 (92·1) | 15 (88·2) | 0·639 | 0·130 |
| Caffeine (days) | 76 (56–91) | 79 (67–96) | 0·574 | 0·215 |
SMD indicates standardized mean differences between arms.
Data are given as N (%) or median (IQR).
Invasive ventilation included high-frequency oscillatory ventilation and synchronized intermittent mandatory ventilation.
IUGR: intra-uterine growth retardation; CRIB: Clinical Risk Index for Babies; Hb: hemoglobin; RBC: Red blood cell; PLT: platelet; PMA: postmenstrual age; ROP: retinopathy of prematurity; BPD: bronchopulmonary dysplasia; IVH: intraventricular hemorrhage; PDA: patent ductus arteriosus; NEC: necrotizing enterocolitis.