Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial-statistical analysis plan for a multicenter randomized controlled trial.

"Declarations Ethics approval and consent to participateThe study is and will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Dutch law (Medical Research Involving Human Subjects Act). The study protocol (study ID number NL67770.058.18) is evaluated and approved by the MREC of the LUMC (reference P18.218). Parental consent is required before trial participation. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. The equipment used in this trial was either designed and built by LUMC (for 3 participating centers) or purchased from Concord Neonatal B.V. (Leiden, The Netherlands; for 6 participating centers). ABtP, SBH, and AHvK are members of the Scientific Advisory Board of Concord Neonatal B.V., but have no financial relationship or support. The company has no role in the design of the study; in the collection, analysis, or interpretation of data; or in the writing of the manuscript. Competing interests The authors declare that they have no competing interests. The equipment used in this trial was either designed and built by LUMC (for 3 participating centers) or purchased from Concord Neonatal B.V. (Leiden, The Netherlands; for 6 participating centers). ABtP, SBH, and AHvK are members of the Scientific Advisory Board of Concord Neonatal B.V., but have no financial relationship or support. The company has no role in the design of the study; in the collection, analysis, or interpretation of data; or in the writing of the manuscript."

"Funding The trial is funded by The Netherlands Organisation for Health Research and Development (project number 852001902). AtP is a 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 was sponsored by the Gisela Thier Fund (Leiden)."

"Trial registration ClinicalTrials.gov NCT03808051. Registered on 17 January 2019."