Physiological-based cord clamping in very preterm infants — Randomised controlled trial on effectiveness of stabilisation

Abstract

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 30À60 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 AE 2:37 min in the PBCC (n = 20) and 1:02 AE 0:30 min in the DCC group (n = 17). Infants receiving PBCC needed less time to reach respiratory stability (PBCC 5:54 AE 2:27 min; DCC 7:07 AE 2:54 min; mean difference corrected for gestational age À1:19 min, 95% CI [À3:04À0:27]), 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.

Versorgung und Reanimation des Neugeborenen nach der Geburt

“…Mittlerweile sind zwar Geräte verfügbar, die die Durchführung von Reanimationsmaßnahmen an der Seite der Mutter ermöglichen. Erste Studien zeigen, dass bei solchen Neugeborenen eine verzögerte Abnabelung durchführbar ist [ 109 – 111 ]. Der optimale Abnabelungszeitpunkt bleibt für reanimationspflichtige Neugeborene allerdings weiterhin unklar.…”

Perinatal stabilisation of infants born with congenital diaphragmatic hernia: a review of current concepts

“…A consistent definition for physiological stability has not been established yet, but the goal is to assess adequate lung aeration. We decided to use physiological parameters as heart rate and oxygenation as proxy for aeration, because of its simplicity and is analogous to what is currently used in a trial evaluating the outcomes of PBCC in very preterm neonates 58. The PinC trial is designed to detect the impact of PBCC on clinical outcomes, for example, the occurrence of PH diagnosed in the first 24 hours after birth.…”

“…We decided to use physiological parameters as heart rate and oxygenation as proxy for aeration, because of its simplicity and is analogous to what is currently used in a trial evaluating the outcomes of PBCC in very preterm neonates. 58 The PinC trial is designed to detect the impact of PBCC on clinical outcomes, for example, the occurrence of PH diagnosed in the first 24 hours after birth. In parallel, there are other ongoing and anticipated initiatives evaluating intact cord resuscitation in CDH infants in Denver (CO, USA) and France (nationwide), respectively.…”

The Assisted Breathing before Cord Clamping (ABC) Study Protocol

“…As noted above, however, the critical factor in the timing of the cord clamping may be related to the onset of respiration rather than the time elapsed. Whilst this was suggested years ago [ 7 , 8 ], there has been a recent resurgence of studies examining “physiologic” cord clamping once breathing is fully established [ 9 , 10 ]. To date, most of these studies are small feasibility studies, although larger clinical studies are underway or have been proposed [ 11 ].…”