Infant admitted to the neonatal intensive care unit undergoing testing for suspected (or confirmed) infection, or bowel concerns Neonatal Diseases
Conditions
Interventions
No changes to clinical care. Point of care tests will be performed on saliva, stool, blood or urine, from beginning of screening episode to physiological and nutritional recovery, discharge from the n
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infant admitted to the neonatal intensive care unit (from 22 weeks gestation to 6 months postnatal age) 2. Infant undergoing testing for suspected (or confirmed) infection, or bowel concerns 3. Written informed consent from parents
Exclusion criteria
Exclusion criteria: 1. Parents unwilling to consent 2. Infants being screened at or shortly after birth for risk factors alone but who are clinically well 3. Infants known to have severe multi-system congenital abnormalities. Infants known to have congenital gastrointestinal abnormalities at admission will be excluded for the first 48 hours, but eligible after this if infection or new bowel concerns occur 4. Infants undergoing therapeutic hypothermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For each assay: positive and negative predictive values for each diagnostic category and area under the curve analysis to identify the best cut-off values from the time of screening to full physiological recovery | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactJanet Berrington
Outcome results
None listed