Clinical trial Recruiting at 1 site Interventional Ages Any age to 6 Hours

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.

More Hypoglycemia trials

Quick facts

Study typeInterventional
AgesAny age to 6 Hours
SexAll
Enrollment70 (estimated)
SponsorUniversity of Campania Luigi Vanvitelli
Academic / other
Locations3 sites (Avellino and 2 other locations)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedAugust 1, 2026
Study endsDecember 1, 2026
Registry record updatedAugust 21, 2024
Trial IDNCT06563687 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.