--- title: "Cereblon (CRBN) as an Early Prognostic Biomarker in Paediatric Sepsis: Study Protocol" id: "bmj-open-13-development-of-cereblon-crbn-as-an-early-prognostic-biomarker-in-paediatric" canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-13-development-of-cereblon-crbn-as-an-early-prognostic-biomarker-in-paediatric" content_type: "clinical_feed_article" specialty: "Pediatrics" source_name: "BMJ Open" source_url: "http://bmjopen.bmj.com/cgi/content/short/16/8/e121640?rss=1" published_at: "2026-08-18T10:29:16.000Z" evidence_level: "Journal Feed" license: "CC-BY-NC-4.0 / Informational Use" --- # Cereblon (CRBN) as an Early Prognostic Biomarker in Paediatric Sepsis: Study Protocol ## Provenance & Clinical Metadata - **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-13-development-of-cereblon-crbn-as-an-early-prognostic-biomarker-in-paediatric - **Specialty:** [Pediatrics](https://medichelpline.com/clinical-feed/pediatrics.md) - **Primary Source:** BMJ Open - **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/8/e121640?rss=1) - **Published At:** 2026-08-18T10:29:16.000Z - **Evidence Rating:** Journal Feed ## Executive GIST (TL;DR) - Paediatric sepsis is a major cause of child morbidity and mortality, particularly in resource-limited settings, and requires improved early prognostication for better triage and timely interventions. - Current biomarkers and scoring systems have limitations in specificity, operational complexity, and generalisability across settings. - **Cereblon (CRBN)** is a multifunctional protein involved in immune modulation; prior adult sepsis data show variable associations with outcomes but its role in paediatric sepsis is unknown. - This document describes a prospective observational study in a PICU to evaluate CRBN expression as an early prognostic biomarker in children with sepsis. - The study will enroll 240 children aged 2 months to 15 years using consecutive non-probability sampling. - Clinical data will include admission and 24-hour **pSOFA** (Pediatric Sequential Organ Failure Assessment) scores. - Blood drawn at admission will be assayed for CRBN mRNA by quantitative real-time PCR and CRBN protein by **ELISA**. - The primary outcome is the association of CRBN levels with **28-day mortality**. - Secondary outcomes include correlations of CRBN with pSOFA, C-reactive protein, duration of mechanical ventilation, and PICU length of stay. - Comparative analyses between survivors and non-survivors will be performed; correlations will use Pearson or Spearman tests as appropriate. - Prognostic performance will be evaluated with ROC curves and AUC; Youden-derived cut-offs will be reported. - Multivariable regression will adjust for key confounders when assessing CRBN's prognostic value. - Ethical approval was obtained from the Institutional Ethics Committee, All India Institute of Medical Sciences, Raebareli (IEC Code-2024-4-EMP-EXP-9); written informed consent from guardians will be obtained. - Results will be reported following **STROBE** guidelines and disseminated via peer-reviewed publications and conferences. ## Clinical Analysis & Structured Key Points Introduction Paediatric sepsis remains a formidable challenge in global child health, contributing significantly to morbidity and mortality, especially in resource-constrained settings. Accurate early prognostication of disease trajectory is imperative for effective triage and timely intervention; however, existing biomarkers and clinical scoring systems are often limited by insufficient specificity, operational complexity or limited applicability across diverse clinical settings. One potential avenue for improving early prognostication is investigating novel biomarkers. Cereblon (CRBN), a multifunctional protein implicated in immune modulation, has shown variable associations with outcomes in adult sepsis, while its role in paediatric sepsis remains unexplored. This study aims to assess the potential of CRBN expression as an early prognostic biomarker in paediatric sepsis, thereby informing clinical decision-making and improving patient outcomes. Methods and analysis This prospective observational paediatric intensive care unit (PICU)-based study will enrol 240 children aged 2 months to 15 years with sepsis using a consecutive non-probability sampling method. Pediatric Sequential Organ Failure Assessment (pSOFA) scores will be recorded at admission and at 24 hours. Blood samples will be collected at admission to assess CRBN mRNA expression by quantitative real-time PCR and protein levels by ELISA. The primary outcome will be the correlation of CRBN with 28-day mortality. Secondary outcomes will assess its correlation with the pSOFA score, C-reactive protein, duration of mechanical ventilation and duration of PICU stay. CRBN levels will be compared between survivors and non-survivors, and correlations with pSOFA score, inflammatory markers and clinical outcomes will be assessed using Pearson's or Spearman's tests as appropriate. Prognostic performance will be assessed using Receiver operating characteristics (ROC) curve and area under curve (AUC) value with Youden-derived cut-offs. Multivariable regression will be performed to adjust for key confounders. Ethics and dissemination Ethical approval was obtained from the Institutional Ethics Committee, All India Institute of Medical Sciences, Raebareli, prior to study initiation (IEC Code-2024-4-EMP-EXP-9). Written informed consent will be obtained from parents or guardians. The study findings will be disseminated through peer-reviewed publications and scientific conferences. The reporting of study results will adhere to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines to ensure transparency and completeness. ## Related Clinical Research - [Reanalysis of Prenatal Acetaminophen and Neurodevelopmental Disorders Using Bias-Correction Methods](https://medichelpline.com/clinical-feed/medrxiv-0-testing-claimed-associations-of-prenatal-acetaminophen-with-neurodevelopmental.md) - [Balanced Fluid versus 0.9% Saline for Children With Septic Shock: NEJM Randomized Trial](https://medichelpline.com/clinical-feed/pubmed-42028918.md) (DOI: 10.1056/NEJMoa2601969) - [High AUROC can hide threshold failure in sepsis transcriptomic classifiers: preprocessing stabilit](https://medichelpline.com/clinical-feed/plos-one-13-high-auroc-can-mask-decision-failure-in-sepsis-transcriptomic-classifiers.md) - [Therapeutic coma in non‑convulsive status epilepticus: higher complications, longer ICU stay, and](https://medichelpline.com/clinical-feed/pubmed-42701136.md) (DOI: 10.1007/s00415-026-14090-8) - [Entropy-Based Framework to Quantify Dynamic Epistemic Uncertainty in Clinical LLM Reasoning](https://medichelpline.com/clinical-feed/medrxiv-1-novel-entropy-based-framework-for-quantifying-dynamic-epistemic-uncertainty-in.md) ## Navigation - [← Back to Pediatrics Feed](https://medichelpline.com/clinical-feed/pediatrics.md) - [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md) ## Medical & Regulatory Disclaimer > [!CAUTION] > MedicHelpline content is structured for research, educational, and professional discovery purposes. 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