---
title: Modulation of Molecular Fingerprinting in Pediatric Sepsis
nct_id: NCT02055105
overall_status: RECRUITING
sponsor: "Phoenix Children's Hospital"
study_type: OBSERVATIONAL
primary_condition: Systemic Inflammatory Response Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02055105.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02055105"
ct_last_update_post_date: 2025-11-12
last_seen_at: "2026-05-12T06:21:34.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Modulation of Molecular Fingerprinting in Pediatric Sepsis

**NCT ID:** [NCT02055105](https://clinicaltrials.gov/study/NCT02055105)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Phoenix Children's Hospital
- **Conditions:** Systemic Inflammatory Response Syndrome
- **Start Date:** 2014-03
- **Completion Date:** 2027-10
- **CT.gov Last Update:** 2025-11-12

## Brief Summary

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.

## 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.

## Eligibility

- **Minimum age:** 1 Year
- **Maximum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **50 Healthy Patients** — Healthy non-immunocompromised patients between 1-18 years old

## Interventions

- **miRNA in Sepsis** (PROCEDURE) — miRNA in Sepsis

## Primary Outcomes

- **Risk of Mortality** _(time frame: Duration of hospital stay, an expected average of 3 weeks)_ — Will compare PRISM 3 scores from baseline to hospital discharge.

## Secondary Outcomes

- **Organ Failure** _(time frame: Duration of hospital stay, an expected average of 3 weeks)_
- **Organ Dysfunction** _(time frame: Duration of hospital stay, an expected average of 3 weeks)_
- **Patient acuity** _(time frame: Duration of hospital stay, an expected average of 3 weeks)_

## Locations (2)

- Phoenix Children's Hospital, Phoenix, Arizona, United States — _RECRUITING_
- Phoenix Children's Hospital, Phoenix, Arizona, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.phoenix children's hospital|phoenix|arizona|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02055105.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02055105*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*