A Phase 4 interventional study of Hydrocortisone in Hypoxic-Ischemic Encephalopathy, Asphyxia and Hypotension, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged Up to 72 Hours. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Semmelweis University · Phase 4, Interventional, and Treatment
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.
The ultimate goal of the present study, is to describe a new approach of more personalized and safe care to infants with birth asphyxia and hemodynamic instability.
Asphyxiated infants often present with multiorgan failure and low blood pressure. Therapeutic hypothermia, the standard of care, could worsen hemodynamic instability; therefore, treatment of cardiovascular impairment represents a major challenge in this clinical setting. An association was previously described between hypotension and low serum cortisol values in this patient population, and it was suggested that relative adrenal insufficiency (RAI) is an important factor in the circulatory compromise of these patients. In the "CORTISoL" clinical trial, it was also demonstrated that low-dose hydrocortisone therapy was effective in the treatment of cardiovascular impairment in asphyxiated neonates; however, some gaps remain in the knowledge on optimal dosing. Importantly, steroid therapy should be administered at the lowest effective dose and for the shortest possible duration in this vulnerable population.
In the current pharmacokinetic study, the investigators propose a stepwise approach to more detailed understanding of RAI and hydrocortisone pharmacokinetics in asphyxiated neonates. The findings would certainly aid clinical decision-making and allow for more personalized therapeutic interventions for the treatment of hemodynamic instability.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard dose of hydrocortisone therapy in neonates for hypotension is 0.5 mg/kg every 6 hours.
Drug: Hydrocortisone
The modified dose of hydrocortisone therapy will be determined based on the pharmacokinetic results.
Drug: Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Also known as: Solu-Cortef
Mean blood pressure increase
5 mmHg increase in mean arterial blood pressure after drug administration
Time frame: 2 hours
Cardiovascular management
Length, cumulative and peak dose of inotrope treatment
Time frame: 72 hours
Presence of relative adrenal insufficiency at baseline
Low serum cortisol level at baseline
Time frame: Before hydrocortisone administration within max. 72 hours
MRI outcome
Brain injury on MRI examinations
Time frame: 4-10 days
Long term neurodevelopmental outcome
Performance on motor and mental scales of Bayley III scales of infant development
Time frame: 18-42 month
Multiorgan failure
Presence of multiorgan failure during hypothermia
Time frame: 72 hours
Plan to share: No
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Studies of the drug tested here: Hydrocortisone