NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)
- Conditions
- Neonatal Diabetes
- Registration Number
- NCT04831723
- Lead Sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Brief Summary
The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life.
The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10784
- Babies having a routine NBS screening test.
- Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset & parts of Wiltshire)
- Parent decides to opt-out of the blood glucose test feasibility study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Normal range of capillary blood glucose in newborns at day 5 of life 12 months
- Secondary Outcome Measures
Name Time Method Validation of laboratory procedures 12 months
Trial Locations
- Locations (4)
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
University Hospitals Dorset
🇬🇧Poole, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom