Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
Recruiting
Phase 4
Interventional Study
Hypoxic-Ischemic Encephalopathy
Asphyxia
Hypotension
Circulatory Failure Neonatal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 72 Hours
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Semmelweis University · Other
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About This Trial
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 hy…
Trial Locations
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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 hypoth…
Contacts