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Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02567305
Enrollment
200
Registered
2015-10-02
Start date
2015-09-30
Completion date
2020-01-31
Last updated
2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Detailed description

Severe infection resulting in sepsis is recognized as a leading cause of morbidity and mortality worldwide (Stehr and Reinhart, 2013). The incidence of sepsis in developed nations has been increasing while overall mortality is decreasing, but still remains around 30% (Mayr et al., 2014). Moreover, morbidity in survivors is often functionally devastating, and may include neurological impairment, chronic organ dysfunction, increased days admitted to hospital, and high rates of mortality postdischarge (Prescott et al., 2014). Emotional, social, and financial costs to individuals and health care systems are immense (Brun-Buisson et al., 2003). Neutrophils are the first line of innate immune defense against infectious agents. In addition, neutrophils' ability to eliminate pathogens by phagocytosis and/or degranulation, it has recently been demonstrated that neutrophils can bind to and kill a wide range of microorganisms by forming neutrophil extracellular traps (NETs) (Brinkmann et al., 2004). This novel mechanism consists of the release of web-like structures of DNA decorated with histones and antimicrobial proteins, known as NETs. Microbes are immobilized in these traps, which contain a lethal concentration of antimicrobial agents killing a broad range of microorganisms, including gram-negative and gram-positive bacteria, fungi, viruses, and protozoa (Brinkmann et al., 2004, Fuchs et al., 2010, Camicia et al., 2014). The role of NETs in pediatric infection is not well understood. We hypnotize that children are capable of forming NETs and that NETosis plays an important role in pediatric sepsis. 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.

Interventions

OTHERMarkers of NET formation

i.e. Plasma DNA, Histone, MPO, DNase

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Signed informed consent by the parent or guardian of the patient 2. Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch) 3. Suspicion of sepsis infection

Design outcomes

Primary

MeasureTime frameDescription
Neutrophil Extracellular Traps2 weeksNeutrophil Extracellular Traps are measured by serum markers

Secondary

MeasureTime frameDescription
Sepsis2 weeksSepsis is defined according to the Goldstein criteria 2015.

Countries

Germany

Contacts

Primary ContactMichael Boettcher, M.D.
m.boettcher@uke.de+4915222815153
Backup ContactKonrad Reinshagen, M.D. Ph.D.
k.reinshagen@uke.de+494088908232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026