Table 2. Primary and Secondary Outcomes of the Study Groups.
| Variables | No. (%) | ||
|---|---|---|---|
| Preterm formula fortification (n = 59) | Human milk fortifier (n = 63) | Mean difference/relative risk (95% CI) | |
| Primary outcome | |||
| In-hospital weight gain, mean (SD), g/kg/d | 15.7 (3.9) | 16.3 (4.0) | −0.5 (−1.9 to 0.7) |
| Secondary outcomes | |||
| Anthropometry | |||
| Length gain, mean (SD), cm/wk | 0.83 (0.4) | 0.86 (0.4) | −0.03 (−0.05 to 0.12) |
| Head circumference gain, mean (SD), cm/wk | 0.64 (0.3) | 0.69 (0.4) | −0.05 (−0.07 to 0.09) |
| EUGR at 40 wk PMA, No./total No. (%) | 29/40 (73) | 42/52 (81) | 0.89 (0.71 to 1.13) |
| No. of episodes of feed intolerance, per 1000 patient-days | 2/1442 (1.4) | 12/1771 (6.8) | 0.19 (0.04 to 0.95)a |
| Age at regaining birth weight, median (IQR), d | 11 (8 to 14) | 11 (8 to 14) | NA |
| Neonates requiring increase of feed volume >180 mL/kg | 4 (7) | 8 (13) | 0.53 (0.17 to 1.68) |
| NEC stage 2 or more | 0 | 3 (5) | NA |
| Late-onset sepsis | 9 (15) | 10 (16) | 0.96 (0.42 to 2.2) |
| Duration of hospital stay, median (IQR), d | 24 (10 to 43) | 34 (15 to 47) | NA |
| Metabolic bone disease | 3 (5) | 4 (6) | 0.8 (0.19 to 3.43) |
| Cholestasis | 3 (5) | 5 (8) | 0.64 (0.16 to 2.56) |
| Anemia of prematurity | 8 (14) | 16 (25) | 0.53 (0.25 to 1.15) |
| PDA | 15 (25) | 16 (25) | 1.0 (0.54 to 1.84) |
| ROP requiring laser | 5 (8) | 4 (6) | 1.33 (0.38 to 4.73) |
| Moderate to severe BPD | 24 (41) | 20 (32) | 1.28 (0.80 to 2.06) |
| IVH grade >2, No./total No. (%) | 2/47 (4) | 2/52 (4) | 1.11 (0.16 to 7.54) |
| Death | 1 (2) | 6 (10) | 0.18 (0.02 to 1.43) |
Abbreviations: BPD, bronchopulmonary dysplasia; IVH, intraventricular hemorrhage; IQR, interquartile range; NA, not applicable; NEC, necrotizing enterocolitis; PDA, patent ductus arteriosus; PMA, postmenstrual age; ROP, retinopathy of prematurity.
a
Incidence rate ratio (with 95% confidence interval) calculated using the negative binomial regression model.