Optimizing hydrocortisone therapy for newborns undergoing hypothermia treatment after asphyxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cardiac Arrest: Using Ultrasound to Find Hidden Blood Flow

  This study tests whether patients who have out-of-hospital cardiac arrest but no pulse still show some blood flow on ultrasound and whether that finding relates to survival.

  Recruiting University of Massachusetts, Worcester · Denver, Colorado and 7 other locations · NCT07897370

• Perfusion Index as a Predictor of Spinal Anesthesia–Induced Hypotension in Day-Case Knee Arthroscopy

  This study looks to see if a baseline perfusion index can predict low blood pressure after spinal anesthesia in healthy adults having knee arthroscopy.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle\Ankara · NCT07747441

• Wireless NIRS Sensor Use in the NICU for Monitoring on Neonates

  A wireless NIRS sensor is tested on infants in the NICU to see how well it stays on and how it notes brain signals when used alongside standard wired sensors.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732244

• Pupil light reflex to predict low blood pressure after spinal anesthesia in cesarean deliveries

  Doctors want to see if a quick eye-pupil test done before spinal anesthesia can predict who might develop low blood pressure after a cesarean delivery.

  Recruiting Al-Azhar University · Damietta · NCT07678723

• Neonatal Neurological Observation With Video AI

  This study tests a real-time, non-contact video AI system to help monitor brain health in newborns with suspected brain injury during their hospital stay.

  Recruiting Artemis AI Labs · New York, New York and 1 other locations · NCT07628829

• Pulse palpation vs arterial blood pressure in circulatory shock

  This study tests how well feeling for a pulse at typical sites matches the actual arterial blood pressure in adults with circulatory shock or risk of failure.

  Recruiting Region Stockholm · Stockholm, Stockholm County · NCT07609095

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.