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CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005589
First Posted: November 2, 2009
Last Update Posted: April 7, 2017
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.
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
  Purpose

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
Neonatal SEPSIS Enterocolitis, Necrotizing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Measurement of Neutrophil Membrane CD64 as an Early Indication of Neonatal Infection and Necrotising Enterocolitis (NEC).

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: October 2009
Study Completion Date: June 2, 2010
Primary Completion Date: June 2, 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01005589


Locations
United Kingdom
Newcastle upon Tyne NHS foundation Trust
Newcastle, Newcastle-upon-Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: Janet E Berrington Newcastle upon Tyne NHS Foundation Trust
  More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01005589     History of Changes
Other Study ID Numbers: 5026
09/H0905/58
First Submitted: October 30, 2009
First Posted: November 2, 2009
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:
Sepsis
Enterocolitis
Neonatal Sepsis
Enterocolitis, Necrotizing
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infant, Newborn, Diseases