Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates - a Pharmacokinetic Study

What this Trial Is About

Researchers are studying intravenous hydrocortisone therapy in newborns with birth asphyxia who experience low blood pressure while undergoing therapeutic hypothermia. This study aims to better understand how the body processes hydrocortisone under cooled conditions to personalize steroid dosing and improve care for these infants with hemodynamic instability. Previous research suggests that low cortisol levels contribute to blood pressure problems in this vulnerable group, and low-dose hydrocortisone has shown promise with some knowledge gaps remaining. The study compares two hydrocortisone dosing approaches: a standard dose of 0.5 mg/kg every 6 hours and a modified dose adjusted according to pharmacokinetic findings. Participants receive hydrocortisone intravenously during hypothermia treatment, which is the current standard care for asphyxiated newborns. The goal is to find the safest and most effective dosing schedule that matches the infants' changing metabolism during cooling. During the study, newborns will have blood pressure monitored and blood samples taken through existing arterial catheters to measure cortisol levels before and after hydrocortisone administration. Researchers will also assess cardiovascular function over 72 hours, perform MRI scans within 4 to 10 days, and evaluate long-term neurodevelopmental outcomes between 18 and 42 months. Participation involves close clinical monitoring to track how well hydrocortisone supports blood pressure and overall recovery.

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates