Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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.

Eligibility criteria

Qualifiers

women aged 18 years or older

speaks English, Spanish, Portuguese, or Haitian Creole

pregnant >24 weeks gestation with singleton pregnancy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Continuous glucose monitoring
  • Cerebral near-infrared spectroscopy

Treatment groups

114 Participants
are divided into 1 treatment group

Locations

This trial has no locations