Actively Recruiting
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
Led by Semmelweis University · Updated on 2026-04-28
50
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age at least 36 weeks
- Receiving whole-body hypothermia treatment as described by Azzopardi et al.
- Presence of systemic hypotension defined as mean arterial pressure less than the gestational age in weeks
- Hydrocortisone treatment indicated during hypothermia by the attending physician
- Indwelling arterial catheter (umbilical or peripheral) for blood sampling without extra punctures
- Written informed parental consent obtained
You will not qualify if you...
- Infants expected to be older than 6 hours at enrollment (not suitable for cooling)
- Presence of critical congenital abnormalities
- Diagnosed genetic disease
- Written informed consent not available
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Semmelweis University Department of Pediatrics (Bókay street Unit)
Budapest, Pest County, Hungary, 1083
Actively Recruiting
Research Team
D
Dobi Marianna, MD
CONTACT
K
Kata Kovacs, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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