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

Ronny Knol*, Emma Brouwer, Thomas van den Akker, Philip DeKoninck, Nan van Geloven, Graeme R. Polglase, Enrico Lopriore, Ellen Herkert, Irwin K.M. Reiss, Stuart B. Hooper, Arjan B. Te Pas

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

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 SpO2 >90% while using FiO2 <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% 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. Clinical Trial Registration: Netherlands Trial Register (NTR7194/NL7004).

Original languageEnglish
Pages (from-to)26-33
Number of pages8
JournalResuscitation
Volume147
DOIs
Publication statusPublished - 1 Feb 2020
Externally publishedYes

Funding

AtP is recipient of an NWO innovational research incentives scheme (VIDI 91716428). RK received a grant from the Sophia Children’s Hospital Foundation (Rotterdam, S17-14). This project is sponsored by the Gisela Thier Fund (Leiden).

FundersFunder number
Sophia Children's Hospital Foundation
Sophia Children’s Hospital FoundationS17-14
Nederlandse Organisatie voor Wetenschappelijk OnderzoekVIDI 91716428

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