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Table 4 Clinical outcomes of sicker infants 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 = 20)

Control group

(N = 22)

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 (%)

1 (5.00)

9 (40.91)

-a

0.01

0.12(0.02, 0.88)

0.12(0.02, 0.97)

35.91%(6.60, 58.82%)

Bell stage 2, n (%)

1 (5.00)

6 (27.27)

-a

0.10

0.18(0.02, 1.39)

 

22.27%(−4.69, 45.92%)

Bell stage 3, n (%)

0 (0.00)

3 (13.64)

-a

0.23

-c

 

13.64%(−8.79, 35.96%)

Late onset sepsis, n (%)

3 (15.00)

9 (40.91)

3.45

0.06

0.37(0.12, 1.17)

 

25.91%(−4.87, 50.89%)

Clinical sepsis, n (%)

2 (10.00)

3 (13.64)

-a

1.00

0.73(0.14, 3.95)

 

3.64%(−21.58, 27.44%)

Proven sepsis, n (%)

1 (5.00)

6 (27.27)

-a

0.10

0.18(0.02, 1.39)

 

22.27%(−4.69, 45.92%)

Patent ductus arteriosus, n (%)

11 (55.00)

11 (50.00)

0.11

0.75

1.10(0.62, 1.96)

 

5.00%(−26.24, 34.96%)

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

1 (5.00)

4 (18.19)

-a

0.35

0.28(0.03, 2.26)

 

13.18%(−11.92, 36.49%)

Periventricular leukomalacia, n (%)

0 (0.00)

0 (0.00)

 

Bronchopulmonary dysplasia, n (%)

4 (20.00)

8 (36.36)

1.38

0.24

0.55(0.20, 1.55)

 

16.36%(−14.05, 42.81%)

Retinopathy of prematurity, n (%)

4 (20.00)

5 (22.73)

-a

1.00

0.88(0.27, 2.83)

 

2.73%(−25.31, 29.42%)

Cholestasis, n (%)

0 (0.00)

4 (18.19)

-a

0.11

-c

 

18.18%(−5.28, 41.01%)

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

30.40 ± 8.82

44.68 ± 18.95

−3.08(df40)

0.01

−14.29(−23.66, −4.91)

−8.29(− 16.31, −0.27)

-b

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

52.65 ± 21.62

55.91 ± 20.27

−0.50(df40)

0.62

−3.26(− 16.32, 9.80)

 

-b

Rate of weight gain (kg.d), mean ± SD

16.28 ± 3.84

14.49 ± 3.32

1.63(df40)

0.11

1.80(−0.44, 4.03)

 

-b

Days of mechanical ventilation (d), mean ± SD

6.45 ± 4.86

11.00 ± 20.12

−0.99(df40)

0.33

−4.55(−13.89, 4.79)

 

-b

Days of noninvasive ventilation (d), mean ± SD

31.50 ± 18.89

28.50 ± 15.82

0.56(df40)

0.58

3.00(−7.83, 13.83)

 

-b

Indwelling time of PICC (d), mean ± SD

30.60 ± 15.99

30.68 ± 14.39

−0.02(df40)

0.99

−0.08(−9.55, 9.39)

 

-b

Length of hospitalization, mean ± SD

60.50 ± 23.02

62.27 ± 19.54

−0.27(df40)

0.79

−1.77(−15.05, 11.50)

 

-b

  1. Sicker infants were defined as infants whose mechanical ventilation was started within the first 3 postnatal days and continued for at least 3 days or until death. SD: standard deviation. PICC: peripherally inserted central catheter
  2. a Fisher’s exact test
  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 birthweight (g), gestational age (weeks), and histologic chorioamnionitis