Health TrialsbyHealthPanel

Accuracy of Interstitial Continuous Glucose Sensors in Neonates

ConditionsNeonatal HypoglycemiaGestational DiabetesMaternal Obesity Complicating PregnancySmall-for-gestational AgeLarge-for-gestational Age
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

This trial accepts healthy volunteers

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 population

Antenatal floor, labor and delivery unit (L\&D), neonatal intensive care unit (NICU), mother baby unit (MBU), and obstetrics and diabetes clinics at Women and Infants Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

114 Participants
are divided into 1 treatment group
Group A: Pregnant women >24 weeks gestation and their infants2 interventions

Trial outcomes

Primary outcomes

1

Point Accuracy: System agreement analysis

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

Time frame
From time of birth to discharge, an average of 3 days

Secondary outcomes

1

Episodes of neonatal hypoglycemia (NH) by risk factors

Count of neonatal hypoglycemia (NH) episodes in infants born with various maternal and neonatal risk factors (maternal diabetes, maternal gestational glucose intolerance, maternal obesity, fetal growth abnormalities, maternal beta blockers, and preterm delivery) or no risk factors.

Time frame
Between birth to 72 hours after birth
2

NNNS scores

NNNS subscale score quartiles

Time frame
From time of birth to 72 hours after birth, at an average of 48 hours of age
3

ASQ scores

Ages and Stages (ASQ) scores

Time frame
6 months and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women and Infants Hospital of Rhode Island

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: