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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
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International Breastfeeding Journal

ISSN: 1746-4358