CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01005589
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005589

Contacts
Contact: Janet E Berrington +44 (191) 2825197 janet.berrington@nuth.nhs.uk
Contact: Chris D Hall +44 (191) 2231195 chris.hall@nuth.nhs.uk

Locations
United Kingdom
Newcastle upon Tyne NHS foundation Trust Recruiting
Newcastle, Newcastle-upon-Tyne, United Kingdom, NE77DN
Contact: Janet E Berrington    +44 (191) 2825197    janet.berrington@nuth.nhs.uk   
Contact: Chris D Hall    +44 (191) 2231195    chris.hall@nuth.nhs.uk   
Principal Investigator: Janet E Berrington         
Sub-Investigator: Chris D Hall         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
Principal Investigator: Janet E Berrington Newcastle upon Tyne NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Janet Berrington, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01005589     History of Changes
Other Study ID Numbers: 5026, 09/H0905/58
Study First Received: October 30, 2009
Last Updated: October 30, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Neonatal sepsis
Necrotizing enterocolitis
CD64 antigen
Receptors, IgG

Additional relevant MeSH terms:
Enterocolitis
Sepsis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014