Clinical trial NCT02567305: Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
Official title: Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children with suspected 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neutrophil Extracellular Traps
timeFrame: 2 weeks
Secondary outcomes:
measure: Sepsis
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Altona Children's Hospital
Study officials:
References: