Physiological-based cord clamping in very preterm infants: randomised controlled trial on effectiveness of stabilisation

Aim: To test whether stabilising very preterm infants while performing physiological-based cord clamping (PBCC) is at least as effective as the standard approach of time-based delayed cord clamping (DCC).Methods: A randomised controlled non-inferiority study was performed in two centres from May until November 2018, including preterm infants born below 32 weeks of gestational age. Infants were allocated to PBCC or standard DCC. Infants receiving PBCC were stabilised on a purpose-built resuscitation table with an intact umbilical cord. The cord was clamped when the infant had regular spontaneous breathing, heart rate >= 100 bpm and SpO(2) 90% while using FiO(2) 0.40. In infants receiving DCC, the cord was clamped at 30 60 seconds after birth before they were transferred to the standard resuscitation table for further treatment and stabilisation. Primary outcome was time to reach respiratory stability.Results: Thirty-seven infants (mean gestational age 29+0 weeks) were included. Mean cord clamping time was 5:49 +/- 2:37 min in the PBCC (n = 20) and 1:02 +/- 0:30 min in the DCC group (n = 17). Infants receiving PBCC needed less time to reach respiratory stability (PBCC 5:54 +/- 2:27 min; DCC 7:07 +/- 2:54 min; mean difference corrected for gestational age 1:19 min, 95 degrees 6 CI [3:04 0:27]), showing non-inferiority with the pre-defined limit of 1:15 min. No significant differences between the groups were found for maternal blood loss, postpartum haemorrhage, infant temperature at admission or short-term neonatal outcomes.Conclusion: Stabilisation of very preterm infants with physiological-based cord clamping is at least as effective as with standard DCC.Development and application of statistical models for medical scientific researc