Clinical trial

Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Opening soon · Not applicable · 0 countries · Registry ID NCT07133906

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexAll

Healthy volunteersAccepted

ConditionNeonatal Hypoglycemia, Gestational Diabetes, Maternal Obesity Complicating Pregnancy, Small-for-gestational Age, Large-for-gestational Age

Full registry criteria

Inclusion Criteria: * women aged 18 years or older * speaks English, Spanish, Portuguese, or Haitian Creole * pregnant \>24 weeks gestation with singleton pregnancy Exclusion Criteria: * known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff * plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island

Treatments and study arms

Continuous glucose monitoring

Device

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

Cerebral near-infrared spectroscopy

Device

Blinded cerebral near infrared spectroscopy will be assessed

Primary outcomes

Point Accuracy: System agreement analysisFrom time of birth to discharge, an average of 3 days

Number and percent of glucose monitoring (GM) sensor results within the intervals +/- 20% of glucose reference throughout the system measuring range

Study locations

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No public site location was included in this record. Check the original registry for updates.