Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
1 other identifier
observational
200
1 country
2
Brief Summary
This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJune 23, 2017
June 1, 2017
3.3 years
October 1, 2015
June 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Neutrophil Extracellular Traps
Neutrophil Extracellular Traps are measured by serum markers
2 weeks
Secondary Outcomes (1)
Sepsis
2 weeks
Study Arms (2)
Actual Sepsis
For infants below 44 weeks inclusive of corrected age clinical sepsis is defined, according to the Expert Meeting on Neonatal and Pediatric Sepsis (Report on the Expert Meeting on Neonatal and Pediatric Sepsis - 8 June 2010, EMA London). Confirmed sepsis is defined as positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown) For children above 44 weeks corrected age clinical sepsis is defined according to the Goldstein criteria (Goldstein et al, 2005). Confirmed sepsis: positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown)
Suspected Sepsis
None of the above.
Interventions
i.e. Plasma DNA, Histone, MPO, DNase
Eligibility Criteria
All children with suspected sepsis
You may qualify if:
- Signed informed consent by the parent or guardian of the patient
- Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch)
- Suspicion of sepsis infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Altona Children's Hospital
Hamburg, 22763, Germany
Biospecimen
50ul Blood during routine blood sampling
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 2, 2015
Study Start
September 1, 2015
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
June 23, 2017
Record last verified: 2017-06