RecruitingPhase 4NCT05836610

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates - a Pharmacokinetic Study


Sponsor

Semmelweis University

Enrollment

50 participants

Start Date

Sep 21, 2021

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 72 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hydrocortisone for people with asphyxia, circulatory failure neonatal, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydrocortisone

intravenous bolus hydrocortisone therapy during hypothermia treatment


Locations(1)

Semmelweis University Department of Pediatrics (Bókay street Unit)

Budapest, Pest County, Hungary

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NCT05836610


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