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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
Sponsor:
Collaborators:
Gertrude Von Meissner Foundation
European Society of Intensive Care Medicine
Swiss National Fund for Scientific Research
Information provided by:
University Hospital, 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.

Condition or disease
Prematurity Neonatal 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
1
Premature infants of less than 28 weeks of gestational age
2
Premature infants of more than 28 weeks and less than 32 weeks of gestational age
3
Term newborns
4
Adults



Primary Outcome Measures :
  1. Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens [ Time Frame: at delivery ]

Secondary Outcome Measures :
  1. Leukocyte phenotype, opsonophagocytic function during neonatal sepsis [ Time Frame: 1 week after recruitment ]

Biospecimen Retention:   Samples With DNA
Serum cDNA


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All premature infants delivered at the University Hospitals of Geneva
Criteria

Inclusion Criteria:

  • Premature or term delivery

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866567


Locations
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Switzerland
University Hospitals of Geneva
Geneva, Geneva 14, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Gertrude Von Meissner Foundation
European Society of Intensive Care Medicine
Swiss National Fund for Scientific Research
Investigators
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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

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Responsible Party: Pierre TISSIERES, MD; MSc, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00866567     History of Changes
Other Study ID Numbers: MatPed 08-017
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: March 2009

Keywords provided by University Hospital, Geneva:
prematurity
VLBW
sepsis
innate immunity

Additional relevant MeSH terms:
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Sepsis
Premature Birth
Neonatal Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases