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Completed

NCT Number: NCT04831723

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

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.

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Key information

Conditions

Neonatal Diabetes

Sex eligibility

All sexes

Study type

Observational

Primary location

Dorset County Hospital, Dorchester, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Normal range of capillary blood glucose in newborns at day 5 of life

    Time frame: 12 months

Secondary outcomes

  1. Validation of laboratory procedures

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • Portsmouth Hospitals NHS Trust

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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