Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
Status:
Recruiting
Trial end date:
2027-09-01
Target enrollment:
Participant gender:
Summary
This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone
therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns.
Patients will be allocated to hydrocortisone supplementation while receiving conventional
inotropic therapy as needed.
The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic
hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the
overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be
reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the
targeted steroid range and biological effects in asphyxiated neonates with relative adrenal
insufficiency. Thus, the investigators are planning to measure initial, baseline serum
cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in
cooled asphyxiated neonates.