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 (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 |