Defects in Opsonophagocytosis in Premature Infants
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|ClinicalTrials.gov Identifier: NCT00866567|
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : February 3, 2010
|Condition or disease|
|Prematurity Neonatal Sepsis|
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:
- Determination of the opsonic capacity of plasma from premature infants, vs. term newborns, and identification possible molecular innate immune defect(s) in preterm plasma.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Defects in Opsonophagocytosis in Premature Infants as a Factor for the Development of Neonatal Sepsis|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Premature infants of less than 28 weeks of gestational age
Premature infants of more than 28 weeks and less than 32 weeks of gestational age
- Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens [ Time Frame: at delivery ]
- Leukocyte phenotype, opsonophagocytic function during neonatal sepsis [ Time Frame: 1 week after recruitment ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866567
|University Hospitals of Geneva|
|Geneva, Geneva 14, Switzerland, 1211|
|Study Director:||Jerome PUGIN, MD||University Hospitals of Geneva|
|Study Director:||Michel BERNER, MD||University Hospitals of Geneva|
|Principal Investigator:||Pierre TISSIERES, MD, MSc||University Hospitals of Geneva|