Modulation of Molecular Fingerprinting in Pediatric Sepsis

The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.

Study Overview

• Status: Recruiting
• Conditions: Systemic Inflammatory Response Syndrome
• Intervention / Treatment: Procedure: miRNA in Sepsis

Detailed Description

This study will aid in the evaluation of determining the accuracy of these miRNAs in pediatric patients and help in establishing pilot data for additional studies in the future. The testing will include blood samples, urine samples and buccal swabs from patients who meet eligibility at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including updated Pediatric Risk of Mortality (PRISM III) scores and simplified Therapeutic Intervention Scoring System(TISS-28) scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry. Data will be recorded in a de-identified manner on a Microsoft Excel database on a secure institutional server by the institutional staff. Data will then be analyzed to determine correlation of biomarkers to morbidity and mortality for these patients.

• Study Type: Observational
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederick A Willyerd, MD; Phone Number: 6029331784; Email: fwillyerd@phoenixchildrens.com
• Study Contact Backup: Name: Althaia Calla G Ignacio, BSN, MD; Phone Number: 6029333795; Email: aignacio@phoenixchildrens.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Althaia Calla G Ignacio; Phone Number: 8328007256; Email: aignacio@phoenixchildrens.com
      • Contact: Aimee LaBell, BSN, MSN; Phone Number: 6029335307; Email: alabell@phoenixchildrens.com
    • Phoenix, Arizona, United States, 85019
      • Recruiting
      • Phoenix Children's Hospital
      • Contact: Amit Misra, MD; Phone Number: 6029331784; Email: amisra@phoenixchildrens.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children ages 1-18 who are Immune-competent (no previous chronic medical conditions) patients being admitted to the PICU at PCH with concerns for sepsis or those developing sepsis during their admission to the hospital who require care in the PICU.

Description

Inclusion Criteria:

• Age 1 through 18 years
• Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.
• Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock.
• Signed informed consent.

Exclusion Criteria:

• Patients <1 year of age and greater than 18 years of age.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
10 Patients with sepsis or septic shock; Previously healthy, non-immunocompromised patients, between the ages of 1 and 18, who are being admitted to the PCH PICU for sepsis or septic shock, will be enrolled. Blood samples, urine samples and buccal swabs will be obtained from these patients at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including PRISM scores and TISS-28 scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry.	Procedure: miRNA in Sepsis; miRNA in Sepsis
50 Healthy Patients; Healthy non-immunocompromised patients between 1-18 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of Mortality	Will compare PRISM 3 scores from baseline to hospital discharge.	Duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ Failure	Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.	Duration of hospital stay, an expected average of 3 weeks
Organ Dysfunction	Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization	Duration of hospital stay, an expected average of 3 weeks
Patient acuity	Will assess TISS-28 scores throughout hospitalization.	Duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Principal Investigator: Frederick A Willyerd, MD, Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimated): February 4, 2014

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric Sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; RNA, Antisense; Antisense Elements (Genetics); RNA; RNA, Small Untranslated; RNA, Untranslated; MicroRNAs
• Other Study ID Numbers: PHNX-biosep-12159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Principal investigator is undecided if he plans on having a DTA or MTA.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No