Table 2.
Baseline characteristics of patients and clinical outcome comparison by “intention-to-treat” analysis.
| Control arm N = 56 | Intervention arm N = 56 | P | SMD | |
|---|---|---|---|---|
| Gestational age, weeks | 26·1 (25·1–27·0) | 26·4 (25·0–27·4) | 0·779 | 0·041 |
| Weight, g | 755 (663–923) | 808 (700–958) | 0·147 | 0·299 |
| Male/female, % | 34 (60·7)/22 (39·3) | 25 (44·6)/31 (55·4) | 0·129 | 0·326 |
| Twins | 12 (21·4) | 12 (21·4) | 0·999 | <0·001 |
| IUGR | 10 (17·9) | 2 (3·6) | 0·028 | 0·475 |
| Apgar score 1 min | 5 (4–7) | 6 (4–7) | 0·896 | 0·019 |
| Apgar score 5 min | 8 (7–9) | 8 (7–8) | 0·898 | 0·013 |
| CRIB II score | 11 (10·0–13·0) | 11 (9·0–12·3) | 0·226 | 0·242 |
| Hb at birth, g/dL | 15·6 (13·9–16·7) | 15·0 (13·8–16·6) | 0·513 | 0·120 |
| Transfused patients | 45 (80·4) | 49 (87·5) | 0·440 | 0·195 |
| Age at first transfusion, PMA week | 27·6 (26·2–29·0) | 27·8 (26·2–29·7) | 0·699 | 0·001 |
| RBC transfusions (<40 weeks PMA) | 3·0 (1·0–5·0) | 2 (1–6) | 0·929 | 0·067 |
| A-RBC units | 3·0 (1·0–5·0) | 1·0 (0·0–2·0) | 0·001 | 0·615 |
| CB-RBC units | 0·0 (0·0–0·0) | 1·0 (0·0–2·75) | <0·001 | 1·198 |
| RBC transfusions (<30 weeks PMA) | 1·5 (0·0–3·8) | 1·0 (0·3·8) | 0·812 | 0·083 |
| A-RBC units | 1·5 (0·0–3·8) | 0·0 (0·0–1·0) | 0·001 | 0·531 |
| CB-RBC units | 0·0 (0·0–0·0) | 1·00 (0·0–2·0) | <0·001 | 1·003 |
| Patients with PLT transfusions (%) | 7 (12·5) | 12 (21·4) | 0·314 | 0·239 |
| ROP (any stage) | 34 (60·7) | 35 (62·5) | 0·999 | 0·999 |
| Stage 1 | 6 (10·7) | 6 (10·7) | 0·996 | <0·001 |
| Stage 2 | 15 (26·8) | 16 (28·6) | 0·039 | |
| Stage 3 | 13 (23·2) | 13 (23·2) | <0·001 | |
| Plus disease | 11 (19·6) | 10 (17·9) | 0·999 | 0·046 |
| Severe ROP | 16 (28·6) | 14 (25·0) | 0·831 | 0·081 |
| Treated ROP | 13 (23·2) | 12 (21·4) | 0·999 | 0·043 |
| Hyaline membrane disease | 39 (69·4) | 44 (78·6) | 0·388 | 0·203 |
| Sepsis (suspected) | 37 (66·1) | 38 (67·9) | 0·999 | 0·038 |
| Sepsis (documented) | 34 (60·7) | 24 (42·9) | 0·088 | 0·363 |
| IVH (any stages) | 19 (33·9) | 16 (28·5) | 0·837 | 0·078 |
| IVH Stage 1/2 | 13 (23·2) | 9 (16·1) | 0·798 | 0·180 |
| IVH Stage 3/4 | 6 (10·7) | 7 (12·5) | 0·056 | |
| BPD (any stage) | 35 (62·5) | 40 (71·4) | 0·421 | 0·191 |
| Moderate or severe BPD | 26 (46·4) | 24 (42·9) | 0·849 | 0·072 |
| PDA | 24 (42·9) | 30 (53·6) | 0·344 | 0·216 |
| Pulmonary hypertension | 7 (12·5) | 9 (16·1) | 0·787 | 0·102 |
| NEC | 5 (8·9) | 5 (8·9) | 0·999 | <0·001 |
| Antibiotic therapy (days) | 20·5 (14·0–35·3) | 20·0 (12·0–34·0) | 0·709 | 0·036 |
| Antifungal therapy (days) | 14·0 (9·5–24·0) | 11·0 (7·0–34·3) | 0·458 | 0·078 |
| Inotropic drugs (%) | 16 (28·6) | 21 (37·5) | 0·421 | 0·191 |
| Inotropic drugs (days) | 4 (1·5–8·0) | 4·0 (2·0–9·0) | 0·492 | 0·363 |
| Invasive ventilation (%) | 33 (58·9) | 28 (50·0) | 0·224 | 0·180 |
| Invasive ventilation (days) | 4 (0–14) | 5 (0–21) | 0·787 | 0·089 |
| Oxygen therapy (days) | 29 (11–67) | 37 (8–73) | 0·900 | 0·030 |
| Steroid therapy (%) | 28 (50·0) | 33 (58·9) | 0·448 | 0·180 |
| Erythropoietin (%) | 25 (44·6) | 21 (37·5) | 0·564 | 0·146 |
| Surfactant (%) | 41 (73·2) | 41 (73·2) | 0·999 | <0·001 |
| Caffeine (%) | 51 (91·1) | 53 (94·6) | 0·716 | 0·139 |
| Caffeine (days) | 70 (56–84) | 73 (58–85) | 0·621 | 0·152 |
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.