Table 1. Baseline characteristics and clinical outcomes of study participants.
| MODIFIED INTENTION-TO-TREAT | PER-PROTOCOL | |||
| Variable |
Placebo (n = 27) |
POM (n = 28) |
Placebo, Metabolite–ve (n = 15) |
POM, Metabolite +ve (n = 17) |
| Baseline Characteristics | ||||
| Maternal age (years), mean (SD) | 26.9 (6.7) | 24.4 (6.1) | 25.9 (7.3) | 24.7 (6.9) |
| Race, Black, n (%) | 17 (63) | 21 (75) | 9 (60) | 12 (71) |
| Race, White, n (%) | 8 (30) | 7 (25) | 5 (33) | 5 (29) |
| Smoking, n (%) | 7 (26) | 7 (25) | 5 (33) | 4 (24) |
| Substance use, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Sickle cell disease, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Gestational age at enrollment, mean (SD) | 30.5 (2.6) | 30.8 (2.5) | 30.4 (2.8) | 30.8 (2.6) |
| Gestational age at enrollment, median (IQR) | 31 (28, 33) | 31.5 (29, 32.5) | 31 (28, 33) | 32 (29, 33) |
| Estimated fetal weight at enrollment (g), mean (SD) | 1187.3 (374.8) | 1194.5 (380.0) | 1205.7 (414.2) | 1184.6 (428.9) |
| Growth percentile at enrollment, mean (SD) | 6.8 (2.0) | 6.0 (2.1) | 7.3 (2.1) | 6.5 (2.2) |
| Steroids for fetal lung maturity, n (%) | 1 (4) | 2 (7) | 0 (0) | 1 (6) |
| Maternal & Delivery Outcomes | ||||
| Gestational age at delivery, weeks, mean (SD) | 37.4 (1.6) | 36.8 (2.5) | 36.9 (1.7) | 37.1 (2.0) |
| PMA at MRI scan, weeks, mean (SD) | 38.6 (1.3) | 38.3 (1.6) | 38.2 (1.2) | 38.1 (1.5) |
| Preterm birth <37 weeks, n (%) | 4 (15) | 7 (25) | 3 (20) | 4 (24) |
| Preterm birth <34 weeks, n (%) | 0 (0) | 3 (11) | 0 (0) | 2 (12) |
| Mode of delivery (vaginal), n (%) | 18 (67) | 19 (68) | 12 (80) | 13 (76) |
| Meconium stained amniotic fluid, n (%) | 1 (4) | 1 (4) | 1 (7) | 1 (6) |
| Neonatal Outcomes | ||||
| Sex, n (%) | 13 (48) | 13 (46) | 8 (53) | 8 (47) |
| Birthweight (g), mean (SD) | 2536.6 (367.5) | 2385.2 (476.7) | 2344.7 (289.7) | 2415.9 (378.8) |
| Birthweight Z-score, mean (SD) | -1.03 (0.70) | -1.09 (0.55) | -1.23 (0.78) | -1.10 (0.57) |
| APGAR score at 1 minute, median (IQR) | 8 (8, 9) | 8 (8, 8) | 8 (7, 8) | 8 (8, 8) |
| APGAR score at 5 minutes, median (IQR) | 9 (9, 9) | 9 (8.5, 9) | 9 (9, 9) | 9 (9, 9) |
| Cord arterial pH, mean (SD) | 7.29 (0.05) | 7.27 (0.05) | 7.30 (0.05) | 7.26 (0.05) |
| Cord arterial base excess, mean (SD) | -2.55 (1.69) | -2.97 (1.25) | -2.54 (1.40) | -3.00 (1.34) |
| Respiratory distress syndrome, n (%) | 5 (19) | 6 (21) | 3 (20) | 1 (6) |
| MODIFIED INTENTION-TO-TREAT | PER-PROTOCOL | |||
| Variable |
Placebo (n = 27) |
POM (n = 28) |
Placebo, Metabolite–ve (n = 15) |
POM, Metabolite +ve (n = 17) |
| Baseline Characteristics | ||||
| Maternal age (years), mean (SD) | 26.9 (6.7) | 24.4 (6.1) | 25.9 (7.3) | 24.7 (6.9) |
| Race, Black, n (%) | 17 (63) | 21 (75) | 9 (60) | 12 (71) |
| Race, White, n (%) | 8 (30) | 7 (25) | 5 (33) | 5 (29) |
| Smoking, n (%) | 7 (26) | 7 (25) | 5 (33) | 4 (24) |
| Substance use, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Sickle cell disease, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Gestational age at enrollment, mean (SD) | 30.5 (2.6) | 30.8 (2.5) | 30.4 (2.8) | 30.8 (2.6) |
| Gestational age at enrollment, median (IQR) | 31 (28, 33) | 31.5 (29, 32.5) | 31 (28, 33) | 32 (29, 33) |
| Estimated fetal weight at enrollment (g), mean (SD) | 1187.3 (374.8) | 1194.5 (380.0) | 1205.7 (414.2) | 1184.6 (428.9) |
| Growth percentile at enrollment, mean (SD) | 6.8 (2.0) | 6.0 (2.1) | 7.3 (2.1) | 6.5 (2.2) |
| Steroids for fetal lung maturity, n (%) | 1 (4) | 2 (7) | 0 (0) | 1 (6) |
| Maternal & Delivery Outcomes | ||||
| Gestational age at delivery, weeks, mean (SD) | 37.4 (1.6) | 36.8 (2.5) | 36.9 (1.7) | 37.1 (2.0) |
| PMA at MRI scan, weeks, mean (SD) | 38.6 (1.3) | 38.3 (1.6) | 38.2 (1.2) | 38.1 (1.5) |
| Preterm birth <37 weeks, n (%) | 4 (15) | 7 (25) | 3 (20) | 4 (24) |
| Preterm birth <34 weeks, n (%) | 0 (0) | 3 (11) | 0 (0) | 2 (12) |
| Mode of delivery (vaginal), n (%) | 18 (67) | 19 (68) | 12 (80) | 13 (76) |
| Meconium stained amniotic fluid, n (%) | 1 (4) | 1 (4) | 1 (7) | 1 (6) |
| Neonatal Outcomes | ||||
| Sex, n (%) | 13 (48) | 13 (46) | 8 (53) | 8 (47) |
| Birthweight (g), mean (SD) | 2536.6 (367.5) | 2385.2 (476.7) | 2344.7 (289.7) | 2415.9 (378.8) |
| Birthweight Z-score, mean (SD) | -1.03 (0.70) | -1.09 (0.55) | -1.23 (0.78) | -1.10 (0.57) |
| APGAR score at 1 minute, median (IQR) | 8 (8, 9) | 8 (8, 8) | 8 (7, 8) | 8 (8, 8) |
| APGAR score at 5 minutes, median (IQR) | 9 (9, 9) | 9 (8.5, 9) | 9 (9, 9) | 9 (9, 9) |
| Cord arterial pH, mean (SD) | 7.29 (0.05) | 7.27 (0.05) | 7.30 (0.05) | 7.26 (0.05) |
| Cord arterial base excess, mean (SD) | -2.55 (1.69) | -2.97 (1.25) | -2.54 (1.40) | -3.00 (1.34) |
| Respiratory distress syndrome, n (%) | 5 (19) | 6 (21) | 3 (20) | 1 (6) |
BMI–body mass index; IQR–interquartile range; POM–pomegranate; PMA–postmenstrual age; SD–standard deviation