Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

Launched by SEMMELWEIS UNIVERSITY · Apr 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of hydrocortisone, a type of steroid, to help treat low blood pressure in newborns who have experienced a lack of oxygen at birth and are undergoing a cooling treatment called hypothermia. The researchers want to find out how the body processes hydrocortisone during this cooling therapy, as lower body temperatures may change how effectively the drug works. By understanding this better, they hope to personalize the amount of hydrocortisone given to these infants to ensure it's just right for their needs.

To be eligible for this trial, babies need to be at least 36 weeks old and have low blood pressure while receiving the cooling treatment. They should also have a special catheter in place to take blood samples easily. Parents will need to give their consent for their child to participate. If your baby meets these criteria, they may be able to join the study. Throughout the trial, researchers will measure hormone levels in the blood before and after giving hydrocortisone to see how well it works in these circumstances. This study is currently looking for participants, and it could help improve treatments for newborns with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • gestational age ≥ 36 weeks
• • provision of whole-body hypothermia treatment (as described by Azzopardi et al.)
• • presence of systemic hypotension (defined as a mean arterial pressure less than the gestational age in weeks)
• • indication for hydrocortisone treatment during hypothermia by the attending physician
• • indwelling arterial catheter to take blood samples without additional painful punctures: umbilical arterial catheter or peripheral arterial catheter
• • written informed parental consent
• Exclusion Criteria:
• • infants who are expected to be \> 6 hours of age (not suitable for cooling)
• • critical congenital abnormalities
• • genetic disease
• • signed informed consent is unavailable