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Table 2 Clinical outcomes between the OAC group and control group at the time of discharge

From: Oropharyngeal administration of colostrum for preventing necrotizing enterocolitis and late-onset sepsis in preterm infants with gestational age ≤ 32 weeks: a pilot single-center randomized controlled trial

Clinical outcome

OAC group

(N = 127)

Control group

(N = 125)

t/x2-value

P-value

Relative risk/Mean difference (95% CI)

Relative risk/ Mean difference

(95% CI)*

Rate difference (95% CI)

NEC (Bell stage 2 or 3), n (%)

3 (2.36)

13 (10.40)

6.85

0.01

0.23 (0.07, 0.78)

0.23 (0.06, 0.84)

8.04% (1.36, 15.31%)

Bell stage 2, n (%)

3 (2.36)

10 (8.00)

4.09

0.04

0.30 (0.08, 1.05)

 

5.64% (−0.62, 12.45%)

Bell stage 3, n (%)

0 (0.00)

3 (2.40)

-a

0.12

-c

 

2.40% (−1.67, 7.38%)

Late onset sepsis, n (%)

6 (4.72)

17 (13.60)

5.98

0.01

0.35 (0.14, 0.85)

0.36 (0.14, 0.95)

8.88% (1.12, 16.93%)

Clinical sepsis, n (%)

3 (2.36)

6 (4.80)

-a

0.33

0.49 (0.13, 1.93)

 

2.44% (−3.23, 8.49%)

Proven sepsis, n (%)

3 (2.36)

11 (8.80)

4.98

0.03

0.27 (0.08, 0.94)

0.31 (0.08, 1.14)

6.44% (0.04, 13.41%)

Patent ductus arteriosus, n (%)

45 (35.43)

33 (26.40)

2.41

0.12

1.34 (0.92, 1.95)

 

9.03% (−2.93, 20.64%)

Intraventricular hemorrhage (grade 3 or 4), n (%)

2 (1.57)

9 (7.20)

4.78

0.03

0.22 (0.05, 0.99)

0.32 (0.06, 1.65)

5.63% (−0.22, 12.17%)

Periventricular leukomalacia, n (%)

0 (0.00)

1 (0.80)

-a

0.50

-c

 

0.80% (−2.94, 5.03%)

Bronchopulmonary dysplasia, n (%)

7 (5.51)

10 (8.00)

0.62

0.43

0.69 (0.27, 1.75)

 

2.49% (−4.60, 9.76%)

Retinopathy of prematurity, n (%)

18 (14.17)

16 (12.80)

0.10

0.75

1.11 (0.59, 2.07)

 

1.37% (−7.78, 10.49%)

Cholestasis, n (%)

3 (2.36)

9 (7.20)

3.25

0.07

0.33 (0.09, 1.18)

 

4.84% (−1.28, 11.48%)

Age of achieving full enteral feeding (d), mean ± SD

23.13 ± 9.45

28.50 ± 14.80

−3.44 (df250)

0.01

−5.38 (−8.45, −2.30)

−4.54 (− 7.04, − 2.01)

-b

Age of achieving full oral feeding (d), mean ± SD

34.14 ± 16.27

35.03 ± 17.54

−0.42 (df250)

0.68

−0.89 (−5.09, 3.31)

 

-b

Rate of weight gain (kg.d), mean ± SD

13.47 ± 3.83

13.20 ± 3.42

0.58 (df250)

0.56

0.27 (−0.64, 1.17)

 

-b

Indwelling time of PICC (d), mean ± SD

24.67 ± 11.44

24.86 ± 13.19

−0.12 (df250)

0.91

−0.19 (−3.25, 2.88)

 

-b

Days of mechanical ventilation (d), mean ± SD

1.02 ± 3.02

1.94 ± 9.29

−1.06 (df250)

0.29

−0.92 (−2.63, 0.79)

 

-b

Days of noninvasive ventilation (d), mean ± SD

14.74 ± 14.31

13.49 ± 13.26

0.72 (df250)

0.47

1.25 (−2.17, 4.68)

 

-b

Breast milk feed rate, n (%)

108 (85.04)

103 (82.40)

0.32

0.57

1.03 (0.93, 1.15)

 

2.64% (−7.11, 12.39%)

Days of breast milk feeds (d), mean ± SD

30.41 ± 20.92

29.93 ± 17.97

0.20 (df250)

0.85

0.48 (−4.36, 5.32)

 

-b

Length of hospitalization (d), mean ± SD

41.12 ± 16.31

43.14 ± 17.15

0.96 (df250)

0.34

−2.02 (−6.17, 2.13)

 

-b

  1. IQR interquartile range, SD standard deviation, PICC peripherally inserted central catheter
  2. a Fisher’s exact test: χ2 value cannot be calculated
  3. b measurement data: Rate difference and 95% CI cannot be calculated
  4. c RR and 95% CI cannot be calculated
  5. *The relative risk/mean difference was adjusted for sex, birthweight (g), gestational age (weeks), TRIPS score, and histologic chorioamnionitis