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NOT YET RECRUITING
NCT07133906

Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

Summary

Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

114

Start Date

2025-09

Completion Date

2027-06

Last Updated

2025-08-21

Healthy Volunteers

Yes

Interventions

DEVICE

Continuous glucose monitoring

A blinded Abbott Freestyle Libre 3 Pro will be placed on the newborn

DEVICE

Cerebral near-infrared spectroscopy

Blinded cerebral near infrared spectroscopy will be assessed