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Defects in Opsonophagocytosis in Premature Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00866567
Enrollment
80
Registered
2009-03-20
Start date
2008-10-31
Completion date
2009-09-30
Last updated
2010-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis, Prematurity

Keywords

prematurity, VLBW, sepsis, innate immunity

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.

Interventions

None listed

Sponsors

Gertrude Von Meissner Foundation
CollaboratorOTHER
European Society of Intensive Care Medicine
CollaboratorOTHER
Swiss National Fund for Scientific Research
CollaboratorOTHER
University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Premature or term delivery

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frame
Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogensat delivery

Secondary

MeasureTime frame
Leukocyte phenotype, opsonophagocytic function during neonatal sepsis1 week after recruitment

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026