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 (Hct≧65%)
|
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
|