Table 4. Safety assessment.
| Complication | Placebo (n = 34) |
POM (n = 37) |
Risk Difference1 (%) | Relative Risk2 | SE2 | χ2 | P3 |
|---|---|---|---|---|---|---|---|
| NICU admission, n (%) | 1 (3) | 3 (8) | 5.1 | 2.76 | 0.05 | 0.62 | |
| Special care nursery admission, n (%) | 10 (29) | 10 (27) | -2.4 | 0.92 | 0.11 | 0.05 | 0.82 |
| Respiratory distress, n (%) | 7 (21) | 9 (24) | 3.7 | 1.18 | 0.10 | 0.14 | 0.71 |
| Resuscitation at delivery, n (%) | 5 (15) | 8 (22) | 6.9 | 1.47 | 0.09 | 0.57 | 0.45 |
| Intraventricular hemorrhage, n (%) | 0 (0) | 0 (0) | 0.0 | - | - | NA | NA |
| Sepsis, n (%) | 2 (0) | 1 (3) | -3.2 | 0.46 | 0.05 | 1.00 | |
| Necrotizing enterocolitis, n (%) | 0 (0) | 0 (0) | 0 | - | - | NA | NA |
NICU–neonatal intensive care; POM–pomegranate; SE–standard error
1 Absolute effect size calculated as the mean difference for continuous variables, and the risk difference (%) for categorical variables (Placebo = reference)
2 Relative effect size calculated as Cohen’s d for continuous variables, and the relative risk for categorical variables (Placebo = reference). For analyses with zero in one or more cells, 0.5 was added to each cell prior to calculation of the relative risk and its standard error (SE). Corresponding SE are reported.
3 Fisher’s exact test (2-sided) used to compare proportions by group where expected cell size < 5.