Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
Recruiting now · Phase 4
Conditions studied: Hypoxic-Ischemic Encephalopathy, Asphyxia, Hypotension, Circulatory Failure Neonatal
In brief
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.
Key facts
- Study ID
- NCT05836610
- Run by
- Semmelweis University
- People needed
- 50
- Starts
- 2021-09-21
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-04-28
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- infants who are expected to be > 6 hours of age (not suitable for cooling)
- critical congenital abnormalities
- genetic disease
- signed informed consent is unavailable
Where it is running
- Semmelweis University Department of Pediatrics (Bókay street Unit) — Budapest, Pest County, Hungary (enrolling)
Full record on ClinicalTrials.gov
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