CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis
|ClinicalTrials.gov Identifier: NCT01005589|
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : April 7, 2017
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
|Condition or disease|
|Neonatal SEPSIS Enterocolitis, Necrotizing|
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||Measurement of Neutrophil Membrane CD64 as an Early Indication of Neonatal Infection and Necrotising Enterocolitis (NEC).|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2, 2010|
|Actual Study Completion Date :||June 2, 2010|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005589
|Newcastle upon Tyne NHS foundation Trust|
|Newcastle, Newcastle-upon-Tyne, United Kingdom, NE77DN|
|Principal Investigator:||Janet E Berrington||Newcastle upon Tyne NHS Foundation Trust|