Table 3.
Clinical course and outcomes of study infants.
| Probiotics | Placebo | P values | |
|---|---|---|---|
| Mortality | 0 | 0 | NE |
| Healthcare-associated infections (HABSI or UTI or SSI or VAP or pleural infection or peritonitis or meningitis or viral infection) | 4 (13.3%) | 6 (19.3%) | 0.731 |
| HABSI before commencing trial supplements | 0 | 1 (3%) | 1.000 |
| HABSI after commencing trial supplements | 0 | 2 (6.5%) | 0.492 |
| Duration of antibiotics before commencement of trial supplements (days) | 5 (IQR: 4–7) (range: 2–10) | 5 (IQR: 3–6) (range: 1–11) | 0.336 |
| Duration of antibiotics after\commencement of trial supplements (days) | 3 (IQR: 0–6) (range: 0–31) | 2 (IQR: 0–5) (range: 0–13) | 0.305 |
| Total duration of antibiotics (days) | 9 (IQR: 4–13) (range: 2–34) | 6 (IQR: 5–10) (range: 1–22) | 0.312 |
| Cholestatic jaundice | 1 (3.3%) | 1 (3.2%) | 1.000 |
| Sepsis due to the administered probiotic organism | 0 | 0 | NE |
| Duration of PN (days) | 13.9 (IQR: 9–24) (range: 0–46) | 10.1 (IQR: 6.9–21.3) (range: 0–58.7) | 0.246 |
| EBM to commence feeds | 30 (100%) | 28 (93.3%) | 0.492 |
| Time to commence feeds after surgery (days) | 3 (IQR: 2–5) (range: 0–10) | 2 (IQR: 1–4) (range: 0–9) | 0.023 |
| Time to full enteral feeds after surgery (days) | 12 (IQR: 8–16) (range: 0–46) | 9 (IQR: 6–15) (range: 1–52) | 0.306 |
| Exclusive EBM at discharge | 24 (80%) | 22 (71%) | 0.554 |
| Use of formula milk | 6 (20%) | 9 (29%) | 0.554 |
| Duration of hospital stay (days) | 27.5 (IQR: 16–37) (range: 10–102) | 20 (IQR: 13–31) (range: 10–67) | 0.094 |
| Z-scores for weight at discharge minus at birth | −0.93 (SD 0.52) | −0.79 (SD 1.00) | 0.486 |
| Z-scores for head circumference at discharge minus at birth | −0.20 (SD 0.63) | −0.70 (SD 0.84) | 0.011 |
| Z-scores for length at discharge minus at birth | −0.40 (SD 1.02) | −0.14 (SD 1.20) | 0.455 |
Bold values indicate statistical significance p < 0.05.
EBM expressed breast milk, NE not estimable, HABSI healthcare-associated bloodstream infections, UTI urinary tract infection, SSI surgical site infection, VAP ventilator-associated pneumonia, EBM expressed breast milk, IQR interquartile range, NE not estimable, SD standard deviation.