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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