CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

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ClinicalTrials.gov Identifier: NCT01005589

Recruitment Status : Completed

First Posted : November 2, 2009

Last Update Posted : April 7, 2017

Sponsor:

Information provided by (Responsible Party):

Newcastle-upon-Tyne Hospitals NHS Trust

Study Description

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

Condition or disease
Neonatal SEPSIS Enterocolitis, Necrotizing

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Study Design


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

Genetic and Rare Diseases Information Center resources: Necrotizing Enterocolitis

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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 ]

Eligibility Criteria

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 Posted:	November 2, 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:


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

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