Continuous Glucose Monitoring in HIE

Launched by UNIVERSITY OF CAMPANIA LUIGI VANVITELLI · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of continuous glucose monitoring (CGM) in newborns who have a condition called hypoxic ischemic encephalopathy (HIE), which can occur when a baby does not get enough oxygen at birth. The goal is to see if using CGM helps keep blood sugar levels within a healthy range better than standard care. Researchers will compare two groups of newborns: one group will use CGM for 72 hours, while the other group will receive standard care without CGM. They will look at how well each method controls blood sugar levels and how often babies experience high or low blood sugar.

To be eligible for this trial, newborns must weigh more than 1.8 kg, be born after 35 weeks of pregnancy, and be less than 6 hours old. They must also have moderate to severe HIE due to a lack of oxygen during birth. However, babies with serious birth defects, metabolic disorders, infections, or those who are very ill and unlikely to survive will not be included. Families considering participation can expect close monitoring of their baby's blood sugar levels and will help researchers understand if CGM can improve care for newborns with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Birth weight \>1.8kg
• • Gestation \>35 weeks
• • Aged \<6hours
• • Moderate or severe HIE following perinatal asphyxia
• Exclusion Criteria:
• • Major congenital malformations
• • Inborn errors of metabolism,
• • Congenital infections
• • Imminent death