Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates (UniCort)
Hypoxic-Ischemic Encephalopathy, Asphyxia, Hypotension
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring Hypothermia treatment, Relative adrenal insufficiency, Hydrocortisone supplementation, Hydrocortisone pharmacokinetics, Hypoxic-Ischemic Encephalopathy, Asphyxia
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
Sites / Locations
- Semmelweis University Department of Pediatrics (Bókay street Unit)Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard dose hydrocortisone
Modified dose hydrocortisone
The standard dose of hydrocortisone therapy in neonates for hypotension is 0.5 mg/kg every 6 hours.
The modified dose of hydrocortisone therapy will be determined based on the pharmacokinetic results.