Defects in Opsonophagocytosis in Premature Infants

Defects in Opsonophagocytosis in Premature Infants as a Factor for the Development of Neonatal Sepsis

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Switzerland
  • Geneva 14
    • Geneva, Geneva 14, Switzerland, 1211
      • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All premature infants delivered at the University Hospitals of Geneva

Description

Inclusion Criteria:

• Premature or term delivery

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens	at delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Leukocyte phenotype, opsonophagocytic function during neonatal sepsis	1 week after recruitment

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: European Society of Intensive Care Medicine; Swiss National Fund for Scientific Research; Gertrude Von Meissner Foundation
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (Estimate): March 20, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: sepsis; prematurity; innate immunity; VLBW
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Sepsis; Premature Birth; Neonatal Sepsis
• Other Study ID Numbers: MatPed 08-017