Table 2.
| (a) Baseline demographic characteristics of the two cohorts of infants (Cohort 1: All infants not determined to be infected. These infants received their randomized formula for a minimum of 8 weeks. Other than those infants in Cohort 2 who were followed for 52 weeks and included in Cohort 1, infants in Cohort 1 were discontinued from the study at week 8; Cohort 2: Infants determined not to be infected who were followed for 52 weeks) | ||||||
|---|---|---|---|---|---|---|
| Cohort 1(Uninfected, 8 wk) | Cohort 2 (Uninfected, 52 wk) | |||||
|
| ||||||
| Characteristic | Concentrated * (n=996) | Standard ** (n=1002) | All Infants (n=1998) | Concentrated * (n=127) | Standard ** (n=126) | All Infants (n=253) |
| Sex – no. (%) | ||||||
| Males | 528 (53) | 513 (51) | 1041 (52) | 68 (54) | 69 (55) | 137 (54) |
| Females | 468 (47) | 489 (49) | 957 (48) | 59 (46) | 57 (45) | 116 (46) |
| Age-days | ||||||
| Mean ± SD | 7.6 ± 4.2 | 7.3 ± 4.1 | 7.5 ± 4.2 | 7.5 ± 3.9 | 7.0 ± 4.0 | 7.2 ± 3.9 |
| 25th percentile | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
| Median | 8.0 | 8.0 | 8.0 | 7.0 | 7.0 | 7.0 |
| 75th percentile | 11.0 | 11.0 | 11.0 | 11.0 | 10.0 | 10.0 |
| Race or ethnic group – no. (%) | ||||||
| White, non-Hispanic | 94 (9) | 108 (11) | 202 (10) | 13 (10) | 13 (10) | 26 (10) |
| Black, non-Hispanic | 585 (59) | 592 (59) | 1177 (59) | 68 (54) | 76 (60) | 144 (57) |
| Hispanic | 309 (31) | 283 (28) | 592 (30) | 46 (36) | 34 (27) | 80 (32) |
| Other | 8 (1) | 19 (2) | 27 (1) | 0 (0) | 3 (2) | 3 (1) |
| Country – no. (%) | ||||||
| U.S. | 888 (89) | 898 (90) | 1786 (89) | 112 (88) | 117 (93) | 229 (91) |
| Brazil | 93 (9) | 81 (8) | 174 (9) | 13 (10) | 7 (6) | 20 (8) |
| Bahamas | 15 (2) | 23 (2) | 38 (2) | 2 (2) | 2 (2) | 4 (2) |
| Infants from multiple births-no. (%) | 39 (4) | 36 (4) | 75 (4) | 31 (24) | 32 (25) | 63 (25) |
| (b) Descriptive statistics (mean ± SD) for baseline growth parameters among the two cohorts | ||||||
|---|---|---|---|---|---|---|
| Cohort 1(Uninfected, 8 wk) | Cohort 2 (Uninfected, 52 wk) | |||||
|
| ||||||
| Characteristic | Concentrated* (n=996) | Standard ** (n=1002) | All Infants (n=1998) | Concentrated * (n=127) | Standard ** (n=126) | All Infants (n=253) |
| Weight (kg) | 3.13 ± 0.52 | 3.15 ± 0.54 | 3.14 ± 0.53 | 2.95 ± 0.58 | 3.05 ± 0.55 | 3.00 ± 0.57 |
| Length (cm) | 49.33 ± 2.64 | 49.27 ± 2.67 | 49.30 ± 2.65 | 48.69 ± 3.00 | 48.98 ± 2.87 | 48.84 ± 2.94 |
| Head Circumference (cm) | 34.32 ± 1.58 | 34.33 ± 1.64 | 34.32 ± 1.61 | 33.93 ± 1.88 | 34.24 ± 1.57 | 34.09 ± 1.74 |
| Weight for age/gender Z-Score | −0.61 ± 0.95 | −0.56 ± 1.00 | −0.59 ± 0.98 | −0.93 ± 1.04 | −0.73 ± 0.97 | −0.83 ± 1.01 |
| Length for age/gender Z-Score | −0.64 ± 1.21 | −0.68 ± 1.25 | −0.66 ± 1.23 | −0.91 ± 1.34 | −0.76 ± 1.26 | −0.83 ± 1.30 |
| Head Circumference for age/gender Z-Score | −0.55 ± 0.90 | −0.53 ± 0.93 | −0.54 ± 0.92 | −0.76 ± 1.11 | −0.56 ± 0.85 | −0.67 ± 0.99 |
*
26 kcal/oz (87 kcal/100 ml)
**
20 kcal/oz (67 kcal/100 ml)
SD=standard deviation
*
26 kcal/oz (87 kcal/100 ml)
**
20 kcal/oz (67 kcal/100 ml)
SD=standard deviation