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Completed

NCT Number: NCT00866567

Defects in Opsonophagocytosis in Premature Infants

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.

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Key information

Conditions

Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infections Inflammation Neonatal SEPSIS Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, Geneva 14, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premature or term delivery

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens

    Time frame: at delivery

Secondary outcomes

  1. Leukocyte phenotype, opsonophagocytic function during neonatal sepsis

    Time frame: 1 week after recruitment

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • European Society of Intensive Care Medicine
  • Gertrude Von Meissner Foundation
  • Swiss National Fund for Scientific Research

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 20, 2009
Registry last updated
Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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