TABLE 1.
Maternal and neonatal characteristics, clinical condition at randomization, and clinical outcome and morbidities during the observation period
| Planned study | Extended study | ||||
| BF-arm (n = 62) | DF-arm (n = 62) | BF-arm (n = 79) | DF-arm (n = 77) | ||
| Maternal characteristics | |||||
| Pregravidic BMI, kg/m2 | Mean (SD) | 23.7 (4.53) | 23.6 (5.70) | 23.4 (4.47) | 24.0 (5.96) |
| Weight gain in pregnancy, kg | Mean (SD) | 9.0 (6.02) | 8.2 (6.14) | 8.7 (6.00) | 8.8 (5.94) |
| Age, y | Median (IQR) | 33.5 (30–38) | 34.5 (30–39) | 34 (30–38) | 34 (30–39) |
| Chronic diabetes | n (%) | 0 (0.0) | 1 (1.6) | 0 (0.0) | 1 (1.3) |
| Chronic hypertension | n (%) | 3 (4.8) | 2 (3.2) | 3 (3.8) | 3 (3.9) |
| Gestational diabetes | n (%) | 10 (16.1) | 11 (17.7) | 11 (13.9) | 14 (18.2) |
| Gestational hypertension | n (%) | 18 (29.0) | 11 (18.0) | 22 (27.8) | 12 (15.8) |
| Caesarean delivery | n (%) | 50 (80.6) | 46 (74.2) | 58 (73.4) | 60 (77.9) |
| Prelabor rupture of membranes | n (%) | 17 (27.4) | 15 (24.2) | 23 (29.1) | 17 (22.1) |
| Assisted reproductive technology | n (%) | 15 (24.2) | 12 (19.4) | 19 (24.1) | 13 (16.9) |
| Neonatal characteristics | |||||
| Boys | n (%) | 29 (46.8) | 31 (50.0) | 36 (45.6) | 37 (48.1) |
| Singletons | n (%) | 35 (56.5) | 40 (64.5) | 47 (59.5) | 46 (59.7) |
| Firstborn | n (%) | 40 (64.5) | 39 (62.9) | 51 (64.6) | 50 (64.9) |
| Gestational age <32 wk* | n (%) | 50 (80.6) | 48 (77.4) | 64 (81.0) | 55 (71.4) |
| VLBW (birth weight ≤1500 g)† | n (%) | 57 (91.9) | 53 (85.5) | 70 (88.6) | 65 (84.4) |
| Small for gestational age‡ | n (%) | 16 (25.8) | 20 (32.3) | 19 (24.4) | 27 (35.1) |
| Weight, g | Mean (SD) | 1166 (297.3) | 1196 (315.7) | 1161 (310.3) | 1214 (311.5) |
| Weight (SDS) | Mean (SD) | −0.36 (1.122) | −0.64 (1.165) | −0.35 (1.120) | −0.74 (1.162) |
| RDS | n (%) | 53 (85.5) | 54 (87.1) | 69 (87.3) | 67 (87.0) |
| Age at randomization, days | Median (IQR) | 9.0 (6–17) | 8.5 (5–14) | 9.0 (6–17) | 8.0 (5–14) |
| Age at start of intervention, days | Median (IQR) | 11.5 (8–17) | 10.5 (7–17) | 12.0 (8–18) | 11.0 (7–17) |
| Intraventricular hemorrhage | n (%) | 5 (8.1) | 2 (3.2) | 8 (10.1) | 3 (3.9) |
| Recovered patent ductus arteriosus | n (%) | 20 (29.4) | 11 (16.2) | 26 (38.5) | 11 (16.2) |
| Clinical outcome and morbidities | |||||
| Length of hospital stay§ | Median (IQR) | 45 (32–63) | 39.5 (29.5–63) | 45.5 (32–63) | 38 (28–56) |
| Transferred to other hospital | n (%) | 6 (9.7) | 5 (8.1) | 7 (8.9) | 5 (6.5) |
| Dead before discharge | n (%) | 1 (1.6) | 1 (1.6) | 1 (1.3) | 1 (1.3) |
| Steroids therapy | n (%) | 1 (1.6) | 1 (1.6) | 1 (1.3) | 1 (1.3) |
| Early sepsis | n (%) | 3 (4.8) | 1 (1.6) | 4 (5.1) | 1 (1.3) |
| Late sepsis | n (%) | 4 (6.5) | 3 (4.8) | 5 (6.3) | 3 (3.9) |
| Necrotizing enterocolitis | n (%) | 1 (1.6) | 1 (1.6) | 1 (1.3) | 1 (1.3) |
BF = bovine milk–derived fortifier; BMI = body mass index; DF = donkey milk–derived fortifier; IQR = interquartile range; RDS = respiratory distress syndrome; SD = standard deviation; SDS = standard deviation score; VLBW = very-low-birth weight.
*Regardless of birth weight.
†Regardless of gestational age at birth.
‡Birth weight below the 10th centile of Italian Neonatal Study (INeS) charts [26].
§Computed on babies discharged to home.