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Case Control Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Pediatr. Dec 9, 2025; 14(4): 110776
Published online Dec 9, 2025. doi: 10.5409/wjcp.v14.i4.110776
Diagnostic and prognostic utility of D-dimer and heparin-binding protein in neonatal sepsis: A prospective case-control study
Hosam-Eldin M Basiouny, Soha S Allam, Alif A Allam, Shimaa Abdelsattar, Mostafa M Sira
Hosam-Eldin M Basiouny, Soha S Allam, Alif A Allam, Mostafa M Sira, Department of Pediatric Hepatology, Gastroenterology and Nutrition, National Liver Institute, Menoufia University, Shebin El-Koom 32511, Menoufia, Egypt
Soha S Allam, Department of Pediatrics, Damietta General Hospital, Damietta 34711, Damietta, Egypt
Shimaa Abdelsattar, Department of Clinical Biochemistry and Molecular Diagnostics, National Liver Institute, Menoufia 32511, Egypt
Author contributions: Basiouny HEM, and Allam SS were involved in the study concept and design; Basiouny HEM, Allam SS, Allam AA, and Sira MM were involved in the recruitment of patients, clinical evaluation, follow-up, and contributed to data acquisition, performed the data interpretation and wrote the manuscript; Sira MM performed the statistical analysis and designed the figures, wrote the final draft; Basiouny HM, Allam SS, Allam AA, Abdelsattar S, and Sira MM reviewed and approved the final manuscript.
Supported by National Liver Institute, Menoufia University, and Damietta General Hospital, Damietta, Egypt.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of the National Liver Institute Menoufia University (NLI-IRB 00003413 FWA0000227). Approval number is 00441.
Informed consent statement: All the legal guardians of the study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: There are no conflicts of interest to report.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement- checklist of items.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Mostafa M Sira, MD, Professor, Department of Pediatric Hepatology, Gastroenterology and Nutrition, National Liver Institute, Menoufia University, Gamal Abdel Nasser Street, Shebin El-Koom 32511, Menoufia, Egypt. msira@liver.menofia.edu.eg
Received: June 16, 2025
Revised: July 9, 2025
Accepted: October 13, 2025
Published online: December 9, 2025
Processing time: 139 Days and 9.4 Hours
Abstract
BACKGROUND

Neonatal sepsis is a serious health problem, with high morbidity and mortality during the first 28 days of life. Clinical diagnosis at presentation is challenging due to the nonspecific signs and symptoms. Although blood culture is the gold standard for diagnosis, it is not always positive.

AIM

To evaluate the diagnostic and prognostic utility of D-dimer and heparin-binding protein (HBP) in neonatal sepsis.

METHODS

This prospective case-control study included 90 neonates in two groups: A sepsis group (n = 45) and a control group (n = 45) without sepsis. Sepsis group was further subdivided based on blood culture results into proven sepsis (n = 28 culture-positive sepsis) and suspected sepsis (n = 17 culture-negative sepsis). All neonates underwent complete history taking, thorough clinical examination and investigations [complete blood count, C-reactive protein (CRP), liver and kidney function tests, plasma D-dimer and HBP].

RESULTS

Levels of CRP, D-dimer and HBP were significantly higher in the sepsis group compared to the controls. At a cutoff value above 517.9 ng/mL, D-dimer outperformed CRP and HBP in distinguishing sepsis group from controls with 95.6% sensitivity and 97.8% specificity. D-dimer was also a better prognostic marker than the neonatal sequential organ failure assessment (nSOFA) for predicting mortality, with 100% sensitivity and 92.5% specificity vs 80% sensitivity and 82.5% specificity. There was a significant positive correlation between CRP, D-dimer and HBP.

CONCLUSION

D-dimer demonstrated superior diagnostic accuracy compared to CRP and HBP in predicting sepsis, and demonstrated superior prognostic accuracy compared to nSOFA in predicting the outcome of neonatal sepsis.

Keywords: C-reactive protein; D-dimer; Heparin-binding protein; Mortality; Neonatal sepsis

Core Tip: Neonatal sepsis is a serious health problem. Although early diagnosis is critical, clinical diagnosis at presentation is difficult due to its nonspecific signs and symptoms. Although blood culture is considered the gold standard for diagnosis, unfortunately, it is not always positive. Efforts have been made to help early suspicion of sepsis, for example, using the hematological scoring system. Nonetheless, there remains a pressing need for novel laboratory markers that can help differentiate bacterial infection from other pathological conditions. The current study investigates the diagnostic and prognostic value of D-dimer and heparin-binding protein in neonatal sepsis.