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CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005589
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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:

  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

Condition or disease
Neonatal SEPSIS Enterocolitis, Necrotizing

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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the neonatal ward who have suspected infection/NEC will be recruited into the study.

Inclusion Criteria:

  • Clinical suspicion of infection / NEC
  • In patient on ward 35 at RVI (neonatal ward)
  • Male or Female
  • Parental consent obtained
  • Neonate

Exclusion Criteria:

  • Known congenital abnormalities (Downs syndrome, leukaemia)
  • Parental consent not obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005589

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United Kingdom
Newcastle upon Tyne NHS foundation Trust
Newcastle, Newcastle-upon-Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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Principal Investigator: Janet E Berrington Newcastle upon Tyne NHS Foundation Trust
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust Identifier: NCT01005589    
Other Study ID Numbers: 5026
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Neonatal sepsis
Necrotizing enterocolitis
CD64 antigen
Receptors, IgG
Additional relevant MeSH terms:
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Neonatal Sepsis
Enterocolitis, Necrotizing
Systemic Inflammatory Response Syndrome
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infant, Newborn, Diseases