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

Royal Devon and Exeter NHS Foundation Trust4 sites in 1 country10,784 target enrollmentJuly 9, 2021

ConditionsNeonatal Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neonatal Diabetes
Sponsor: Royal Devon and Exeter NHS Foundation Trust
Enrollment: 10784
Locations: 4
Primary Endpoint: Normal range of capillary blood glucose in newborns at day 5 of life
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 9, 2021

End Date

June 30, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Responsible Party

Sponsor

Eligibility Criteria

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)