Status:

NOT_YET_RECRUITING

Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Lead Sponsor:

Women and Infants Hospital of Rhode Island

Conditions:

Neonatal Hypoglycemia

Gestational Diabetes

Eligibility:

All Genders

Brief 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 fou...

Detailed Description

Glycemic control in newborns remains a major challenge for neonatal care. One third of U.S. infants are screened for neonatal hypoglycemia (NH) with repeated, painful heel sticks, most commonly based ...

Eligibility Criteria

Inclusion

  • women aged 18 years or older
  • speaks English, Spanish, Portuguese, or Haitian Creole
  • pregnant \>24 weeks gestation with singleton pregnancy

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2027

Estimated Enrollment :

114 Patients enrolled

Trial Details

Trial ID

NCT07133906

Start Date

September 1 2025

End Date

June 1 2027

Last Update

August 21 2025

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