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Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

NCT05836610 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Asphyxia
  • Hypotension
  • Circulatory Failure Neonatal

Interventions

DRUG

Hydrocortisone

intravenous bolus hydrocortisone therapy during hypothermia treatment

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Kata Kovacs, MD, PhD · Semmelweis University

  • Miklós Szabó, MD, PhD · Semmelweis University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Hungary

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836610 on ClinicalTrials.gov