Table 1.
Characteristics of the infants and mothers (Per-Protocol Population).
| Characteristic | Ondansetron (N=45) | Placebo (N=41) |
|---|---|---|
| Infants | ||
| Male sex - # (%) | 23 (51%) | 22 (54%) |
| Median birth weight (range) - grams | 3053 (1940 to 4017) | 3060 (2017 to 4120) |
| Median gestational age (range) - weeks/days | 39/1 (36/0 to 41/2) | 39/0 (37/0 to 40/6) |
| Median Apgar scores at 1 minute (range) | 8 (2 to 9) | 8 (5 to 9) |
| Median Apgar score at 5 minutes (range) | 9 (6 to 9) | 9 (5 to 10) |
| Receipt of any breastmilk in hospital (%) | 18 (40%) | 17 (41%) |
| Mothers | ||
| Ethnicity and race - # (%) | ||
| White non-Hispanic | 35 (78%) | 34 (83%) |
| Black non-Hispanic | 6 (13%) | 4 (10%) |
| White Hispanic | 3 (7%) | 3 (7%) |
| Black + other non-Hispanic | 1 (2%) | 0 (0%) |
| Maternal substance exposure | ||
| Methadone (%) | 38 (84%) | 34 (83%) |
| Heroin (%) | 23 (51%) | 20 (49%) |
| Methamphetamine (%) | 7 (16%) | 5 (12%) |
| Tobacco use (>5 cigarettes day) (%) | 24 (53%) | 18 (44%) |
| Marijuana (%) | 10 (22%) | 7 (17%) |
| Cocaine (%) | 8 (18%) | 9 (22%) |
| Benzodiazepine (%) | 10 (22%) | 7 (17%) |
| PCP (%) | 1 (2%) | 0 (0%) |
| Mother did not receive study drug during labor (%) | 5 (11%) | 7 (17%) |