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Licensed Unlicensed Requires Authentication Published by De Gruyter November 9, 2021

Coagulation parameters in the newborn and infant – the Copenhagen Baby Heart and COMPARE studies

Sofie Taageby Nielsen, Nina Strandkjær, Ida Juul Rasmussen, Malene Kongsgaard Hansen, Rikke Mohr Lytsen, Pia R. Kamstrup, Line Rode, Jens P. Goetze, Kasper Iversen, Henning Bundgaard and Ruth Frikke-Schmidt



The coagulation system is not fully developed at birth and matures during the first months of infancy, complicating clinical decision making within hemostasis. This study evaluates coagulation parameters at birth and two months after birth, and tests whether cord blood can be used as a proxy for neonatal venous blood measurements.


The Copenhagen Baby Heart Study (CBHS) and the COMPARE study comprise 13,237 cord blood samples and 444 parallel neonatal venous blood samples, with a two month follow-up in 362 children.


Because coagulation parameters differed according to gestational age (GA), all analyses were stratified by GA. For neonatal venous blood, reference intervals for activated partial thromboplastin time (APTT) and prothrombin time (PT) were 28–43 s and 33–61% for GA 37–39 and 24–38 s and 30–65% for GA 40–42. Reference intervals for international normalized ratio (INR) and thrombocyte count were 1.1–1.7 and 194–409 × 109/L for GA 37–39 and 1.2–1.8 and 188–433 × 109/L for GA 40–42. Correlation coefficients between umbilical cord and neonatal venous blood for APTT, PT, INR, and thrombocyte count were 0.68, 0.72, 0.69, and 0.77 respectively, and the distributions of the parameters did not differ between the two types of blood (all p-values>0.05).


This study describes new GA dependent reference intervals for common coagulation parameters in newborns and suggests that cord blood may serve as a proxy for neonatal venous blood for these traits. Such data will likely improve clinical decision making within hemostasis among newborn and infant children.

Corresponding author: Ruth Frikke-Schmidt, MD, DMSc, Professor, Chief Physician, Department of Clinical Biochemistry, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark, Phone: +45 3545 4348, Fax: +45 3545 2880, E-mail:

Funding source: The Research Council at Herlev-Gentofte Hospital

Funding source: The Danish Heart Foundation

Funding source: The Regions Research Foundation


We thank the staff at the maternity wards at Herlev Hospital, Hvidovre Hospital, and Rigshospitalet. We are grateful to the staff and participants of the Copenhagen Baby Heart Study and the COMPARE study for their important contributions to the cohorts.

  1. Research funding: This work was supported by the Research Council at Herlev-Gentofte Hospital, The Danish Heart Foundation, and The Regions Research Foundation. The funding organizations played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The research related to human use has complied with all the relevant national regulations, institutional policies, and in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and has been approved by the authors’ Institutional Review Board, the Regional Ethics Committee of the Capital Region of Denmark (H-16001518), and the Danish Data Protection Agency (I-Suite no.: 04546, ID-no. HGH-2016-53).


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Supplementary Material

The online version of this article offers supplementary material (

Received: 2021-09-02
Accepted: 2021-10-25
Published Online: 2021-11-09
Published in Print: 2022-01-27

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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