NCT05836610 Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
| NCT ID | NCT05836610 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Semmelweis University |
| Condition | Hypoxic-Ischemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-09-21 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2021-09-21 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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 Exclusion Criteria: * infants who are expected to be \> 6 hours of age (not suitable for cooling) * critical congenital abnormalities * genetic disease * signed informed consent is unavailable
Contact & Investigator
Kata Kovacs, MD, PhD
PRINCIPAL INVESTIGATOR
Semmelweis University
Frequently Asked Questions
Who can join the NCT05836610 clinical trial?
This trial is open to participants of all sexes, up to 72 Hours, studying Hypoxic-Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05836610 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05836610 currently recruiting?
Yes, NCT05836610 is actively recruiting participants. Contact the research team at mariannadobi@gmail.com for enrollment information.
Where is the NCT05836610 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT05836610 clinical trial?
NCT05836610 is sponsored by Semmelweis University. The principal investigator is Kata Kovacs, MD, PhD at Semmelweis University. The trial plans to enroll 50 participants.