Table 2.
Baseline characteristics of parents and infants fed formula (SF, α-lac-EW or CGMP-RW) * or breast milk (BF), ITT population.
| SF n = 83 |
α-lac-EW n = 81 |
CGMP-RW n = 80 |
p-Value 1 All FF ** |
BF n = 83 |
p-Value 2 All FF vs. BF |
|
|---|---|---|---|---|---|---|
| Birth weight (g) | 3471 ± 452 3 | 3527 ± 440 | 3605 ± 443 | 0.16 | 3540 ± 424 | 0.89 |
| Birth length (cm) | 50.2 ± 2.2 | 50.1 ± 1.9 | 50.5 ± 1.7 | 0.42 | 50.4 ± 1.9 | 0.51 |
| Birth head circumference (cm) |
34.6 ± 1.2 | 35.0 ± 1.3 | 35.0 ± 1.2 | 0.06 | 35.0 ± 1.5 | 0.23 |
| Gestational age (wk) | 39.5 ± 1.2 a | 39.7 ± 1.3 b | 40.1 ± 1.2 | 0.007 | 40.0 ± 1.1 | 0.11 |
| Age at inclusion (d) | 49.3 ± 5.0 | 49.4 ± 4.1 | 49.2 ± 5.8 | 0.97 | 50.5 ± 4.5 | 0.05 |
| Female [n (%)] | 40 (48) | 41 (51) | 40 (50) | 0.95 | 43 (52) | 0.73 |
| Ever breastfed before inclusion [n (%)] | 63 (76) | 66 (78) | 70 (88) | 0.17 | 83 (100) | n/a |
| Days of breast-feeding before inclusion (n) |
15.5 ± 14.6 | 18.0 ± 15.2 | 17.5 ± 13.9 | 0.50 | 50.4 ± 4.6 | n/a |
| Probiotics before inclusion [n (%)] 4 |
28 (34) | 24 (30) | 23 (29) | 0.94 | 13 (16) | 0.007 |
| Twins [n (%)] | 5 (6) | 7 (9) | 4 (5) | 0.63 | 0 (0) | 0.009 |
| Siblings [n (%)] | 54 (65) | 53 (65) | 47 (59) | 0.61 | 45 (54) | 0.15 |
| Maternal age (y) | 31.5 ± 4.8 | 31.1 ± 4.6 | 31.1 ± 4.6 | 0.83 | 32.6 ± 4.2 | 0.026 |
| Maternal origin [n (%)] | ||||||
| Nordic | 77 (93) | 70 (86) | 74 (93) | 0.29 | 75 (90) | 0.96 |
| European (non-Nordic) | 3 (4) | 3 (10) | 3 (4) | 1.0 | 5 (4) | 0.36 |
| Non-European | 3 (4) | 8 (10) | 3 (4) | 0.15 | 3 (4) | 0.58 |
| Maternal higher education [n (%)] 5 | 45(54) | 47 (58) | 57 (71) | 0.067 | 66 (80) | 0.002 |
| Maternal BMI at enrollment (kg/m2) | 27.9 ± 5.2 | 27.9 ± 5.6 | 26.1 ± 4.2 | 0.04 # | 25.2 ± 3.7 | <0.001 |
| Weight gain during pregnancy (kg) |
13.1 ± 6.2 | 13.4 ± 6.6 | 14.7 ± 6.0 | 0.20 | 14.1 ± 5.3 | 0.59 |
| Gestational diabetes [n (%)] | 4 (5) | 2 (3) | 4 (5) | 0.66 | 5 (6) | 0.54 |
| Gestational hypertension [n (%)] |
5 (6) | 8 (10) | 3 (4) | 0.28 | 5 (6) | 0.86 |
| Maternal smoking during pregnancy [n (%)] | 3 (4) | 4 (5) | 3 (4) | 0.61 | 0 (0) | 0.071 |
| Paternal origin [n (%)] 6 | ||||||
| Nordic | 65 (80) a | 68 (86) | 73 (94) | 0.047 | 65 (80) | 0.17 |
| European (non-Nordic) | 6 (7) | 3 (4) | 2 (3) | 0.30 | 10 (12) | 0.015 |
| Non-European | 10 (12) | 8 (10) | 3 (4) | 0.15 | 6 (7) | 0.69 |
| Paternal higher education [n (%)] 5 |
29 (36) | 31 (40) b | 46 (59) | 0.008 | 56 (69) | 0.052 |
| Paternal BMI (kg/m2) | 27.0 ± 4.2 | 27.3 ± 5.8 | 26.0 ± 4.0 | 0.24 | 25.9 ± 4.5 | 0.18 |
| Paternal smoking during pregnancy [n (%)] | 14 (17) | 11 (14) | 5 (7) | 0.12 | 9 (11) | 0.71 |
* SF, standard formula; α-lac-EW, experimental formula with α-lactalbumin-enriched whey; CGMP-RW, experimental formula with reduced CGMP whey.** All FF = infant formula groups combined.1 Chi-square test or Fisher´s exact test for categorical data. ANOVA with post hoc Bonferroni for comparison of means. 2 Chi-square test or Fisher´s exact test for categorical data. Independent samples t-test for comparison of means. 3 Mean ± SD. a SF vs. CGMP-RW. b α-lac-EW vs. CGMP-RW. # ANOVA p = 0.04, although post hoc test showed no significant difference between FF groups. 4 Probiotics: Sempers magdroppar®, wash-out period 7 days before inclusion. 5 University or higher professional education. 6 Information about baseline characteristics available for 238 fathers.