Using continuous glucose monitoring for newborns with brain injury
Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 6 Hours |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 3 sites (Avellino and 2 other locations) |
| Trial ID | NCT06563687 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using continuous glucose monitoring for similar conditions, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Avellino and 2 other locations
- A.O.S.G. Moscati — Avellino, Italy (Not_yet_recruiting)
- University of Campania Luigi Vanvitelli — Naples, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.