Observational Study of miRNA in Pediatric Sepsis

This observational study is looking at how certain tiny molecules called micro RNA (miRNA) change in children with sepsis. Sepsis is a serious condition where the body's response to an infection damages its own tissues and organs. Researchers want to see if these miRNA levels can help identify sepsis early and how they change as children receive treatment. You might be able to join if you are between 1 and 18 years old and are admitted to the hospital with concerns for sepsis, or develop sepsis during your stay. The study aims to understand if miRNA can help predict the risk of death during a hospital stay, which is expected to be about three weeks. The current status of this study is unclear, and it plans to include 50 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any new treatments. It plans to enroll 50 participants.
What's involved
You would provide blood samples, urine samples, and cheek swabs at five different times. Researchers will also collect information about your health during your hospital stay.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, risk of mortality, is measured during the duration of your hospital stay, which is an expected average of 3 weeks.

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NCT02055105

Modulation of Molecular Fingerprinting in Pediatric Sepsis

Recruiting
Not specifiedAges 1–18Observational
Phoenix Children's Hospital
~50 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:miRNA in Sepsis

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Risk of Mortality
Measured over Duration of hospital stay, an expected average of 3 weeks
Systemic Inflammatory Response Syndrome
2 sites across 1 states
Arizona2
  • Frederick A Willyerd, MD · PRINCIPAL_INVESTIGATOR · Phoenix Children's Hospital

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Eligibility criteria

Inclusion

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

Patients \<1 year of age and greater than 18 years of age.
  • Risk of MortalityDuration of hospital stay, an expected average of 3 weeks

    Will compare PRISM 3 scores from baseline to hospital discharge.