Table 2. Primary outcome and secondary outcomes for continuous variables.
| PBCC arm N = 63 |
ECC arm N = 60 |
Mean difference (95% CI)* | p-value | |
|---|---|---|---|---|
| Primary outcome † | ||||
| Mean heart rate between 60 to 120 s after birth (bpm) | 154 (31) | 158 (35) | −6 (−17, 5) | 0.39‡ |
| Subgroup | ||||
| - 32+0 to 35+6 weeks’ gestation | 146 (27); n = 7 |
154 (28); n = 5 |
−6 (−44, 33)** | |
| - Emergency birth ≥36+0 weeks gestation | 163 (30); n = 39 |
166 (36); n = 36 |
−4 (−18, 11)** | |
| - Nonemergency birth ≥36+0 weeks gestation | 135 (30); n = 15 |
142 (28); n = 16 |
−8 (−30, 15)** | |
| Secondary outcomes (continuous variables) # | ||||
| Resuscitation | ||||
| Time from birth to initiate respiratory support (s)^ | 63 [44–79]; n = 40 | 93 [60–180]; n = 28 | −30 (−63, 3) | |
| Time from birth to Pedicap colour change (s)^ | 70 [50–80]; n = 27 | 74 [62–126]; n = 12 | −16 (−46, 14) | |
| Time from birth to first cry (s)^ | 57 [42–121]; n = 62 | 48 [30–68]; n = 60 | 12 (−7, 31) | |
| Infants who did not receive respiratory support: Time between randomisation and first cry (s)^ | 11 [9–18]; n = 23 | 14 [6–18]; n = 32 | −2 (−9, 5) | |
| Time to regular crying (s)^ | 74 [55–128] | 65 [48–90] | 13 (−6, 31) | |
| Maximum fraction of inspired oxygen (%) | 61 (27); n = 24 | 54 (24); n = 20 | 7 (−9, 22) | |
| Time spent with heart rate <100 bpm (s) | 12 (33) | 12 (33) | −0 (−12, 12) | |
| Time spent with heart rate >180 bpm (s) | 155 (187) | 228 (202) | −76 (−142, −10) | |
| Heart rate variability (bpm)~ | 13 (7) | 13 (8) | 0 (−3, 3) | |
| Apgar score at 1 min^ | 7 [5, 8] | 7 [6, 9] | −1.0 (−2.3, 0.3) | |
| Apgar score at 5 min^ | 9 [9, 9] | 9 [9, 9] | 0.0 (−0.0, 0.0) | |
| Apgar score at 10 min^ | 10 [9, 10]; n = 41 | 10 [10, 10]; n = 37 | 0.2 (−0.8, 1.1) | |
| First temperature (°C) | 36.8 (0.5) | 36.9 (0.6) | −0.1 (−0.3, 0.1) | |
| Cord arterial pH | 7.2 (0.1); n = 28 | 7.2 (0.1); n = 33 | 0.0 (−0.0, 0.1) | |
| Cord arterial lactate (mmol/L) | 5.4 (2.2); n = 31 | 5.2 (1.7); n = 35 | 0.2 (−0.8, 1.1) | |
| Cord venous pH | 7.3 (0.1); n = 45 | 7.3 (0.1); n = 42 | −0.0 (−0.0, 0.0) | |
| Cord venous lactate (mmol/L) | 4.1 (1.9); n = 48 | 4.1 (1.5); n = 44 | −0.0 (−0.7, 0.7) | |
| Infant | ||||
| Haematocrit level if measured, within 24 h of birth | 0.55 (0.08); n = 14 | 0.53 (0.07); n = 8 | 0.0 (−0.1, 0.1) | |
| Maternal | ||||
| Maternal blood loss (ml) | 469 (326) | 518 (573) | −38 (−198, 122) |
*Adjusted for the randomisation stratification factors.
**Adjusted for hospital site.
†There were 5 infants (4%) missing the primary outcome measure, thus multiple imputation was not warranted. There was no evidence of an interaction between any of the subgroups within the treatment arm.
‡Calculated from a linear regression model adjusted for the randomisation stratification factors.
#All continuous data are reported as mean (SD) unless marked with ^ where the median [IQR: Q1, Q3] is reported. Sample size is provided if it differs from the group sample size.
^Reported as median [IQR: Q1, Q3].
~Heart rate variability was defined as the standard deviation of heart rate for infants in each arm.
bpm, beats per minute; °C, degrees Celsius; ECC, early cord clamping; h, hours; min, minutes; mmol/L, millimoles per litre; ml, millilitres; PBCC, physiologically based cord clamping; s, seconds.