NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)

Neonatal Diabetes Clinical Trial

Official title: NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neonatal Diabetes

• NCT number: NCT04831723
• Study type: Observational
• Source: Royal Devon and Exeter NHS Foundation Trust
• Status: Completed
• Start date: July 9, 2021
• Completion date: June 30, 2022