Optimizing hydrocortisone therapy for newborns undergoing hypothermia treatment after asphyxia
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates - a Pharmacokinetic Study
This study is testing how to best use hydrocortisone treatment for newborns who have had trouble breathing at birth and are being cooled to help their recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 72 Hours |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest, Pest County) |
| Trial ID | NCT05836610 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the pharmacokinetics of intravenous hydrocortisone therapy in asphyxiated newborns receiving therapeutic hypothermia. The study aims to personalize steroid supplementation by measuring serum cortisol levels before and after hydrocortisone administration. By understanding how hypothermia affects drug metabolism, the researchers hope to determine the optimal dosing of hydrocortisone to improve hemodynamic stability in these vulnerable infants. The ultimate goal is to enhance the safety and effectiveness of care for newborns suffering from birth asphyxia and low blood pressure.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns with a gestational age of 36 weeks or more who are undergoing whole-body hypothermia treatment due to systemic hypotension.
Not a fit: Patients who are older than 6 hours at the time of treatment or have critical congenital abnormalities or genetic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment protocols for asphyxiated neonates, potentially improving their survival and long-term outcomes.
How similar studies have performed: Previous studies have shown that low-dose hydrocortisone can be effective in treating cardiovascular impairment in asphyxiated neonates, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budapest, Pest County
- Semmelweis University Department of Pediatrics (Bókay street Unit) — Budapest, Pest County, Hungary (Recruiting)
Study contacts
- Principal investigator: Kata Kovacs, MD, PhD — Semmelweis University
- Study coordinator: Dobi Marianna, MD
- Email: mariannadobi@gmail.com
- Phone: +36303357529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.