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CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

NCT01005589 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2017-04-07

No results posted yet for this study

Summary

Bacterial infections are a major cause of death in newborn infants. And are linked to complications including: sepsis (an over exaggerated immune response to infection) and necrotising enterocolitis (a potentially fatal inflammatory bowel disease).

Detecting infections at an early stage is difficult in newborns as the signs and symptoms can be non-specific, the most commonly used lab test is to culture a sample of blood, urine or spinal fluid to try and grow and identify any bacteria that is present; however these tests take 24-48 hours to give results, and this means that neonates who present with signs of infection are prescribed broad spectrum antibiotics whilst results are obtained.

The lack of a test that can detect infection at an early stage and give rapid results is one of the major problems in the diagnosis and management of infection in newborns. This study will investigate neutrophils, which are white blood cells that are important in fighting infection. When neutrophils detect and infection they become activated, and produce a protein called CD64 (a cell marker) on their surface, and it is this protein that we want to measure. Neutrophils produce the CD64 protein within 1 hour of first detecting an infection, so we could hopefully detect and treat infections much quicker.

The hypothesis this study will test are:

1. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of infection in neonates AND:
2. Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of NEC in neonates

Conditions

  • Neonatal SEPSIS
  • Enterocolitis, Necrotizing

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Janet E Berrington · Newcastle upon Tyne NHS Foundation Trust

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-06-02
Completion
2010-06-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005589 on ClinicalTrials.gov