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

NCT04831723 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10784

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Neonatal Diabetes

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Timothy Mcdonald · Royal Devon and Exeter NHS Foundation Trust

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831723 on ClinicalTrials.gov