TABLE 1.
Demographic and Clinical Characteristics at Enrollment by Treatment Group for All Infants Randomly Assigned
| Mupirocin Group (n = 80) | Control Group (n = 75) | |
|---|---|---|
| Male sex, n (%) | 45 (56) | 42 (56) |
| Hispanic ethnicity, n (%) | 2 (3) | 4 (5) |
| Race, n (%) | ||
| Asian American | 1 (1) | 1 (1) |
| African American | 22 (28) | 25 (33) |
| White | 50 (63) | 41 (55) |
| Multiracial | 6 (8) | 7 (9) |
| Unknown | 1 (1) | 1 (1) |
| Birth wt, n (%), ga | ||
| <1000 | 29 (36) | 28 (37) |
| 1000–1500 | 23 (29) | 23 (31) |
| >1500 | 26 (33) | 22 (29) |
| Gestational age, n (%), wk | ||
| <28b | 21 (26) | 21 (28) |
| 28c | 59 (74) | 54 (72) |
| Postnatal age at enrollment, median (range), wk | 4 (0–22) | 3 (1–24) |
| Major comorbidities, n (%)d | ||
| NEC | 4 (5) | 1 (1) |
| Respiratory distress syndrome | 60 (75) | 56 (75) |
| Apnea of prematurity | 51 (64) | 48 (64) |
| Surgical procedures | 16 (20) | 14 (19) |
| With indwelling tubes or catheters, n (%) | ||
| Endotracheal tube or tracheostomy | 7 (9) | 6 (8) |
| Central vascular access | 14 (18) | 12 (16) |
| Orogastric tube | 23 (29) | 22 (29) |
| Screening nasal colonizing strain, n (%)e | ||
| MRSA or MRSA plus MSSA | 12 (15) | 8 (11) |
| MSSA | 66 (82) | 67 (89) |
| No positive results on baseline culture | 2 (3) | 0 |
| Pretreatment colonizing site, n (%)f | ||
| Nasal | 72 (90) | 66 (88) |
| Periumbilical | 31 (39) | 26 (35) |
| Perianal | 33 (41) | 18 (24) |
| No. sites colonized, n (%)g | ||
| 0 | 5 (6) | 7 (9) |
| 1 | 30 (37) | 34 (45) |
| 2 | 23 (29) | 20 (27) |
| 3 | 20 (25) | 12 (16) |
Includes all 155 infants evaluable for the ITT analysis.
Four subjects were discharged from the hospital after randomization but before obtaining pretreatment NUP cultures and medical history.
Denotes <28 wk gestation and <8 wk postnatal life.
Denotes ≥28 wk gestation or <28 wk gestation and ≥8 wk of postnatal life.
These categories are not mutually exclusive.
Infants who had a surveillance nasal swab positive for SA were enrolled and randomly assigned.
Positive results on pretreatment NUP cultures were required for infants to be eligible for the mITT analysis.
Cultures were not collected from 2 infants treated with mupirocin and 2 control infants.