Clinical Trial: CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Measurement of Neutrophil Membrane CD64 as an Early Indication of Neonatal Infection and Necrotising Enterocolitis (NEC).
Brief 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:
- Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of infection in neonates AND:
- Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of NEC in neonates
Detailed Summary:
New born infants (neonates) and particularly premature infants are more at risk of developing bacterial infections due to a number of different factors including immature immune systems, and because they are more likely to need invasive procedures such as chest drains that increase the potential for infection.
The signs of infection in babies can be non-specific and difficult to diagnose. Undetected infections which are not treated can quickly lead to sepsis, which is an over-exaggerated response by the immune system which can spread throughout the whole body and attack 'self' tissue leading to organ failure and death. It is therefore vital that infection in neonates can be diagnosed quickly in order to administer the best treatment.
The current 'gold standard' laboratory test for detecting infection is to culture samples of blood, urine or spinal fluid, which allows any bacteria present to be grown in the lab and identified. However this test can take 24-48 hours to give results, and due to the devastating consequences of not treating an infection in neonates it is now common practice to prescribe broad spectrum antibiotics to any neonate who presents with signs of infection and await test results.
This study will look at what happens to the white blood cells that make up part of the immune defence against infection when they encounter an infection. One type of white blood cell that is particularly important in fighting bacterial infections is called the neutrophil, and when it detects an infection, it becomes activated in order to fight it; during this activation process it expresses a protein marker called CD64 on its surface. The CD64 protein is expressed within hours of the onset of bacterial infections, so measuring the CD64 marker could provide much faster results th
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Current Primary Outcome: The primary outcome measure is the CD64 count at the time of presentation with symptoms of infection/NEC. [ Time Frame: At time of initial sepsis evaluation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Newcastle-upon-Tyne Hospitals NHS Trust
Dates:
Date Received: October 30, 2009
Date Started: October 2009
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017
