Skip to main content

Table 2 Primary and Secondary Outcomes Analyzed by Intent to Treat

From: Effects of timing of umbilical cord clamping on preventing early infancy anemia in low-risk Japanese term infants with planned breastfeeding: a randomized controlled trial

 

DCC

ECC

Relative risk (95% CI) / Mean difference (95% CI)

p value

Primary outcome

Spectrophotometric hemoglobin at 4 months (n = 137/DCC = 67,ECC = 70)

12.4

(0.8)

12.3

(0.6)

0.1

[−0.14, 0.35]

0.40

Secondary outcome

Neonates

  1) Anemia (SpHb < 11.0 g/dl) (n = 137/DCC = 67, ECC = 70)

1

(0.7)

0

(0)

0.9

[0.64, 1.25]

0.49

  2) Total serum bilirubin (TsB) (days 3-5) (mg/dl) a (n = 132/DCC = 66, ECC = 66)

12.8

(3.4)

12.2

(3.6)

0.6

[−0.61, 1.80]

0.33

  3) Over the excess level of TsB (%) b (n = 132/DCC = 66, ECC = 66)

6

(9.1)

5

(7.6)

1.2

[0.39, 3.74]

1.00

  4) Phototherapy (%) c (n = 133/DCC = 66, ECC = 67)

7

(10.3)

5

(7.1)

1.4

[0.48, 4.25]

0.37

  5) TcB level (days 1-4) (mg/dl)

   day1 (n = 137/DCC = 68, ECC = 69)

5.0

(1.8)

4.6

(1.9)

0.3

[−0.29, 0.95]

0.29

   day2 (n = 135/DCC = 67, ECC = 68)

8.7

(2.2)

8.6

(2.2)

0.1

[−0.63, 0.87]

0.75

   day3 (n = 126/DCC = 62, ECC = 64)

11.4

(2.6)

10.9

(2.9)

0.5

[−0.45, 1.50]

0.29

   day4 (n = 119/DCC = 58, ECC = 61)

11.9

(2.7)

11.4

(3.1)

0.5

[−0.57, 1.53]

0.37

  6) Hematocrit level (days 3-5) (%) a (n = 132/DCC = 66, ECC = 66)

57.0

(5.2)

52.6

(5.2)

4.4

[2.61, 6.20]

< 0.01*

  7) High hematocrit (Hct65%)

3

(4.6)

2

(3.0)

1.5

[0.26, 8.82]

0.68

  8) Birth weight (g)

3118

(332.5)

3030

(354.5)

88.5

[−27.26, 204.19]

0.13

  9) Vital signs after birth

   After birth

    heart rate (times/mins) (n = 131/DCC = 64, ECC = 67)

154

(15.3)

150

(13.2)

3.9

[−1.05, 8.83]

0.12

    respiration (times/mins) (n = 129/DCC = 63, ECC = 66)

59.3

(9.5)

61

(11.6)

−1.7

[−5.45, 1.96]

0.35

    body temperature (°C) (n = 129/DCC = 63, ECC = 66)

37.0

(0.5)

37.0

(0.5)

0.0

[−0.14, 0.20]

0.75

    SpO2 (%) (n = 132/DCC = 65, ECC = 67)

98

(1.8)

98

(2.0)

−0.3

[−0.93, 0.37]

0.40

   1 h

    heart rate (times/mins)

150

(10.4)

150

(11.8)

0.3

[−3.42, 4.09]

0.86

    respiration (times/mins) n = 137/DCC = 68, ECC = 69)

56

(11.6)

57

(9.1)

0.5

[−4.61, 2.40]

0.54

    body temperature (°C) (n = 137/DCC = 68, ECC = 69)

37.3

(0.5)

37.2

(0.5)

0.0

[−0.14, 0.22]

0.67

    SpO2 (%)

99

(1.2)

99

(1.2)

−0.1

[− 0.48, 0.32]

0.70

   2 h

    heart rate (times/mins) (n = 137/DCC = 67, ECC = 70)

142

(13.3)

140

(12.9)

1.6

[−2.85, 6.00]

0.48

    respiration (times/mins) (n = 137/DCC = 67, ECC = 70)

52

(7.3)

52

(8.9)

−0.3

[−3.09, 2.44]

0.82

    body temperature (°C) (n = 137/DCC = 67, ECC = 70)

37.2

(0.4)

37.2

(0.4)

0.0

[−0.14, 0.15]

0.93

    SpO2 (%) (n = 137/DCC = 67, ECC = 70)

99

(1.1)

99

(1.5)

0.1

[−0.35, 0.54]

0.68

  10) Infant growth

   1 month weight (g) (n = 136/DCC = 67, ECC = 69)

4206

(517.2)

4175

(421.4)

30.1

[−129.64, 189.93]

0.71

   4 month weight (g) (n = 137/DCC = 67, ECC = 70)

6727

(751.1)

6731

(759.7)

−3.3

[−258.62, 252.09]

0.98

  11) Adverse effects

   seizure (%)

0

0

   admitted to NICU within 24 h (%)

0

0

   neonatal death (%)

0

0

Mother

  12) Haemorrhage

   at third stage of labor (g)

288

(224.3)

275

(185.0)

13.3

[−55.84, 82.41]

0.71

   total (until 2 h)

419

(283)

380

(194)

39.0

[−42.43, 120.26]

0.24

  1. Data are presented as mean (SD) or n (%)
  2. a The highest value among blood sampling conducted during days 3-5 were used
  3. b Over the excess value are based on Standard of Imura (1985)
  4. c Two (DCC = 1, ECC = 1) received phototherapy before meeting the standard of phototherapy for prevention. One (ECC = 1) did not received phototherapy even over the level for the standard of phototherapy
  5. *p < .05