NCT00866567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 3, 2010

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

March 19, 2009

Last Update Submit

February 2, 2010

Conditions

PrematurityNeonatal Sepsis

Keywords

prematurityVLBWsepsisinnate immunity

Outcome Measures

Primary Outcomes (1)

  • Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens

    at delivery

Secondary Outcomes (1)

  • Leukocyte phenotype, opsonophagocytic function during neonatal sepsis

    1 week after recruitment

Study Arms (4)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All premature infants delivered at the University Hospitals of Geneva

You may qualify if:

  • Premature or term delivery

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Geneva

Geneva, Geneva 14, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum cDNA

MeSH Terms

Conditions

Premature BirthNeonatal SepsisSepsis

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jerome PUGIN, MD

    University Hospitals of Geneva

    STUDY DIRECTOR

  • Michel BERNER, MD

    University Hospitals of Geneva

    STUDY DIRECTOR

  • Pierre TISSIERES, MD, MSc

    University Hospitals of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 3, 2010

Record last verified: 2009-03

Locations

CH(1)