Defects in Opsonophagocytosis in Premature Infants

NCT ID: NCT00866567

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-09-30

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.

Conditions

Prematurity; Neonatal Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Premature infants of less than 28 weeks of gestational age

No interventions assigned to this group

2

Premature infants of more than 28 weeks and less than 32 weeks of gestational age

No interventions assigned to this group

3

Term newborns

No interventions assigned to this group

4

Adults

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Premature or term delivery

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gertrude Von Meissner Foundation

OTHER

Sponsor Role: collaborator

European Society of Intensive Care Medicine

OTHER

Sponsor Role: collaborator

Swiss National Fund for Scientific Research

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Geneva

Principal Investigators

Jerome PUGIN, MD

Role: STUDY_DIRECTOR

University Hospitals of Geneva

Michel BERNER, MD

Role: STUDY_DIRECTOR

University Hospitals of Geneva

Pierre TISSIERES, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Locations

University Hospitals of Geneva

Geneva, Geneva 14, Switzerland

Countries

Switzerland

Other Identifiers

MatPed 08-017

Identifier Type: -

Identifier Source: org_study_id