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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831723
• Other study ID #: 2107147
• Status: Completed
• Start date: July 9, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10784
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Diabetes

Locations

Country	Name	City	State
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	University Hospitals Dorset	Poole
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	University Hospital Southampton	Southampton

Sponsors (3)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	National Institute for Health Research, United Kingdom, Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal range of capillary blood glucose in newborns at day 5 of life		12 months
Secondary	Validation of laboratory procedures		12 months