CD64 Measurement in Neonatal Infection and Necrotising Enterocolitis

NCT01005589 | Completed

• 2 other identifiers: 502609/H0905/58
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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. 1.Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of infection in neonates AND:
2. 2.Does neutrophil membrane CD64 measurement provide a highly sensitive and specific marker of NEC in neonates

Conditions

Neonatal SEPSIS; Enterocolitis, Necrotizing

Keywords

Neonatal sepsis; Necrotizing enterocolitis; CD64 antigen; Receptors, IgG

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the CD64 count at the time of presentation with symptoms of infection/NEC.

  At time of initial sepsis evaluation

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the neonatal ward who have suspected infection/NEC will be recruited into the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Newcastle upon Tyne NHS foundation Trust

Newcastle, Newcastle-upon-Tyne, NE77DN, United Kingdom

Location

MeSH Terms

Conditions

Neonatal Sepsis; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Janet E Berrington

  Newcastle upon Tyne NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: June 2, 2010
• Study Completion: June 2, 2010
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

GB (1)