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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hungary
Semmelweis University Department of Pediatrics (Bókay street Unit)
RECRUITING
Budapest
Contact Information
Primary
Dobi Marianna, MD
mariannadobi@gmail.com
+36303357529
Backup
Kata Kovacs, MD, PhD
mail.kata.kovacs@gmail.com
+36204969653
Time Frame
Start Date: 2021-09-21
Estimated Completion Date: 2027-09
Participants
Target number of participants: 50
Treatments
Active_comparator: Standard dose hydrocortisone
The standard dose of hydrocortisone therapy in neonates for hypotension is 0.5 mg/kg every 6 hours.
Active_comparator: Modified dose hydrocortisone
The modified dose of hydrocortisone therapy will be determined based on the pharmacokinetic results.
Sponsors
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov

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