Table 2 Primary outcome and nutrition outcomes in the infants included in the mITT analysis.

From: Bovine colostrum as a human milk fortifier for very preterm infants with slow feeding advancement: a randomized controlled trial

Clinical outcomes

n

BC group

n

CF group

Estimate [95% CIs]

p

FI (binary), n (%)

74

24 (32)

72

21 (29)

1.2 [0.6, 2.4]a

0.66

FI (GA < 30 wks), n (%)

44

19 (43)

34

13 (37)

1.4 [0.5, 3.4]a

0.52

FI (GA ≥ 30 wks), n (%)

30

5 (17)

37

8 (22)

0.8 [0.2, 3.1]a

0.75

FI (site A), n (%)

66

22 (33)

65

20 (31)

1.1 [0.5, 2.4]a

0.77

FI (time-to-event)

74

24

72

21

1.2 [0.6, 2.1]b

0.61

TEF120, d

74

21 ± 9

72

20 ± 10

0.13 [−0.03, 0.28]c

0.11

TEF150

71/74

28 ± 12

68/71

26 ± 12

2 [−1, 5]b

0.19

Days on PN, d

74

18.6 ± 9.0

72

19.1 ± 12.2

−0.01 [−0.20, 0.19]c

0.96

Enteral nutrition volume during intervention, mL/kg WT/d

Start

74

109 ± 20

72

112 ± 21

−3 [−10, 3] a

0.71

Day 7

74

140 ± 23

71

141 ± 23

−1 [−8, 7]c

0.86

Day 14

73

151 ± 18

67

152 ± 16

−0.6 [−6, 5]c

0.84

End

52

154 ± 16

57

152 ± 18

1.3 [−4, 8]c

0.67

Protein from the fortifier, g/100 mL feed, median (min-max)

Day 7

74

1.4 [0, 2]

70

1.4 [0, 1.4]

0.9 [−0.8, 0.6]c

0.78

Day 14

73

1.4 [0, 2]

68

1.4 [0, 1.4]

1.4 [−0.4, 1.1]c

0.38

End of intervention

52

1.4 [0, 2.5]

58

1.4 [0, 1.4]

2.0 [−0.1, 1.5]c

0.07

Protein from enteral nutrition, g/kg WT/d

Day 7

74

3.7 ± 1.0

70

3.6 ± 1.1

0.1 [−0.3, 0.4]c

0.98

Day 14

73

4.2 ± 0.9

68

3.9 ± 1.2

0.31 [−0.04, 0.65]c

0.08

Infants needing fortification at the end of intervention, n (%)

74

65 (89%)

72

68 (94%)

0.5 [0.1, 1.7]a

0.24

Infants needing fortification at discharge, n (%)

74

60 (82%)

72

58 (82%)

1.1 [0.4, 2.5]a

0.88

MOM only at the end of intervention, n (%)

74

62 (84%)

72

60 (83%)

1.0 [0.4, 2.5]a

0.94

Infants on breastfeeding at discharge, n (%)

74

61 (82%)

72

62 (86%)

0.8 [0.3, 1.9]a

0.55

  1. aodds ratio; bhazard ratio; cbeta coefficient; dFisher exact test. site A, the site with most enrolments. All values are in mean ± SD unless otherwise specified.
  2. DOL day of life, FI feeding intolerance, GA gestational age, MOM mother’s own milk, PN parenteral nutrition, TEF120(150), time to enteral feeding of 120(150) mL/kg WT/d, WT body weight.
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