Ongoing Clinical Trials for Neonatal Hyperglycaemia
Currently, there is 1 ongoing clinical trial investigating treatment options for neonatal hyperglycaemia, a condition where newborn babies experience temporarily high blood sugar levels. This trial is taking place in France and is testing an oral medication called glibenclamide in very premature infants.
Clinical trial locations
Study on Oral Glibenclamide for Managing High Blood Sugar in Premature Infants Weighing Less Than 1500g
This clinical trial is investigating whether an oral medication called glibenclamide can help manage temporarily high blood sugar levels in very premature babies. The condition being studied occurs when premature infants experience elevated blood sugar levels due to their immature insulin-producing cells not working properly yet. As these babies grow and develop, their ability to produce insulin typically improves naturally.
Who can participate:
- Premature babies born at less than 32 weeks of pregnancy
- Infants weighing less than 1500 grams at birth
- Babies who are currently less than 34 weeks post-menstrual age
- Infants with confirmed high blood sugar levels of 10 mmol/l or higher on two separate blood tests
- Babies who have a secure way to receive fluids through a vein
- Infants who can receive nutrition through their digestive system
- Parents or legal guardians must provide consent
- The infant must be covered by social security
Who cannot participate:
- Infants weighing more than 1500 grams
- Babies who do not have transient (temporary) high blood sugar
- Full-term infants who were not born prematurely
- Babies who cannot take medication by mouth or feeding tube
- Infants with other serious health conditions that might interfere with the study
- Babies already enrolled in another clinical trial
What the trial involves:
The trial tests a medication called glibenclamide, which is given as a liquid suspension (AMGLIDIA 6 mg/mL oral suspension). This medication can be administered through the baby’s mouth or through a feeding tube. Glibenclamide belongs to a class of medications called sulfonylureas, which work by helping the pancreas release more insulin to lower blood sugar levels.
The main goal of the study is to see if glibenclamide can control blood sugar levels over a 72-hour period without needing to use insulin injections. During the treatment, doctors will closely monitor the babies’ blood sugar levels to make sure they remain stable and do not drop too low. They will also assess the infants’ nutritional intake, growth, and watch for any adverse reactions to the medication.
Researchers will continue to observe the babies’ health outcomes until they reach 36 weeks post-menstrual age, checking for any complications. The information gathered from this study could help improve care for premature infants with high blood sugar levels in the future.
Summary
There is currently one clinical trial investigating treatment options for neonatal hyperglycaemia, taking place in France. This trial focuses specifically on very premature infants weighing less than 1500 grams and born before 32 weeks of pregnancy. The study is testing glibenclamide, an oral medication that stimulates insulin release, as an alternative to insulin injections for managing temporarily high blood sugar levels in these vulnerable newborns. The trial represents an important effort to find safer and more convenient treatment options for this condition, which typically resolves as premature infants mature and their bodies develop better blood sugar control.