Defects in Opsonophagocytosis in Premature Infants

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866567
• Other study ID #: MatPed 08-017
• Status: Completed
• Phase: N/A
• First received: March 19, 2009
• Last updated: February 2, 2010
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Premature or term delivery

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Sepsis
• Premature Birth
• Prematurity
• Sepsis

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva	Geneva 14

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Geneva	European Society of Intensive Care Medicine, Gertrud von Meissner Foundation, Swiss National Fund for Scientific Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens		at delivery	No
Secondary	Leukocyte phenotype, opsonophagocytic function during neonatal sepsis		1 week after recruitment	No