Using continuous glucose monitoring for newborns with brain injury
Official title: Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
Run by University of Campania Luigi Vanvitelli · NCT06563687 · Data updated 2026-11-12
This study is testing if using continuous glucose monitoring can help newborns with brain injury keep their blood sugar levels stable and improve their health outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 6 Hours |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 3 sites (Avellino and 2 other locations) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | August 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT06563687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates with a birth weight greater than 1.8 kg, gestation over 36 weeks, and diagnosed with moderate or severe HIE within six hours of birth.
✕Probably not a fit
Patients with major congenital malformations, inborn errors of metabolism, congenital infections, or those facing imminent death will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of continuous glucose monitoring (CGM) in managing glucose levels in neonates diagnosed with moderate to severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia. Neonates will be randomly assigned to receive either CGM or standard care within six hours of birth, and their glucose levels will be monitored for 72 hours. The primary goal is to determine if CGM can increase the time spent within target glucose concentrations, thereby improving outcomes related to glucose variability and preventing extreme glucose levels.
Why it matters
Potential benefit: If successful, this approach could lead to better glycemic control and improved neurodevelopmental outcomes for affected neonates.
How similar studies have gone: Other studies have shown promise in using continuous glucose monitoring for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Campania Luigi Vanvitelli
Naples, Italy Recruiting -
A.O.S.G. Moscati
Avellino, Italy Not yet recruiting -
Monaldi | | AORN - Ospedali dei ColliAORN - Ospedali dei Colli
Naples, Italy Not yet recruiting
Study contacts
- Study coordinator: Paolo Montaldo, PhD
- Email: paolo.montaldo@unicampania.it
- Phone: 0815664023
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.