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

NHS Foundation Trust

Status: Completed

Conditions: Neonatal Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT04831723

2107147

Details and patient eligibility

About

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.

Enrollment: 10,784 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Parent decides to opt-out of the blood glucose test feasibility study.