Clinical trial NCT00866567: Defects in Opsonophagocytosis in Premature Infants
Official title: Defects in Opsonophagocytosis in Premature Infants as a Factor for the Development of Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Neonatal Sepsis
Keywords: prematurity
VLBW
sepsis
innate immunity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Gertrude Von Meissner Foundation
name: European Society of Intensive Care Medicine
name: Swiss National Fund for Scientific Research
First posted: 2009-03-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All premature infants delivered at the University Hospitals of Geneva

Brief summary: The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.

Detailed description: Sepsis is an important problem in preterm infants and carries a significant morbidity and mortality. It is estimated that 20% of premature infants surviving beyond the first three days of life will have one or more culture-proven bacteremic sepsis. There is increasing epidemiologic and biologic evidence suggesting that preterm newborns are more susceptible to infection than term newborns and adults. Immaturity of the immune system, and, in particular, defects in innate responses to pathogens are of foremost importance in the pathogenesis of neonatal sepsis. The aims of the study are the:

1. Determination of the opsonic capacity of plasma from premature infants, vs. term newborns, and identification possible molecular innate immune defect(s) in preterm plasma.
2. Characterization of the role of TLR2 and TLR4 responses in phagocytes from premature infants using classical TLRs agonists. Determination of the capacity of plasma from premature infants to sustain TLR pathways, with a particular attention paid to the possible role of soluble MD-2 in plasma from premature infants in TLR-dependent opsonophagocytosis.
3. Determine prognostic factors for neonatal sepsis. The identification of a quantitative and/or qualitative defect in innate plasma protein(s) in premature newborns has the potential of identifying those infants who are likely to develop a neonatal sepsis.

Eligibility criteria: Inclusion Criteria:

* Premature or term delivery

Exclusion Criteria:

* none

Primary outcomes:
measure: Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens
timeFrame: at delivery
Secondary outcomes:
measure: Leukocyte phenotype, opsonophagocytic function during neonatal sepsis
timeFrame: 1 week after recruitment
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
state: Geneva 14
Study officials:
affiliation: University Hospitals of Geneva
name: Jerome PUGIN, MD
role: STUDY_DIRECTOR
affiliation: University Hospitals of Geneva
name: Michel BERNER, MD
role: STUDY_DIRECTOR
affiliation: University Hospitals of Geneva
name: Pierre TISSIERES, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: