Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates (UniCort)

April 23, 2026 updated by: Kata Kovacs, Semmelweis University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The ultimate goal of the present study, is to describe a new approach of more personalized and safe care to infants with birth asphyxia and hemodynamic instability.

Asphyxiated infants often present with multiorgan failure and low blood pressure. Therapeutic hypothermia, the standard of care, could worsen hemodynamic instability; therefore, treatment of cardiovascular impairment represents a major challenge in this clinical setting. An association was previously described between hypotension and low serum cortisol values in this patient population, and it was suggested that relative adrenal insufficiency (RAI) is an important factor in the circulatory compromise of these patients. In the "CORTISoL" clinical trial, it was also demonstrated that low-dose hydrocortisone therapy was effective in the treatment of cardiovascular impairment in asphyxiated neonates; however, some gaps remain in the knowledge on optimal dosing. Importantly, steroid therapy should be administered at the lowest effective dose and for the shortest possible duration in this vulnerable population.

In the current pharmacokinetic study, the investigators propose a stepwise approach to more detailed understanding of RAI and hydrocortisone pharmacokinetics in asphyxiated neonates. The findings would certainly aid clinical decision-making and allow for more personalized therapeutic interventions for the treatment of hemodynamic instability.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard dose hydrocortisone
The standard dose of hydrocortisone therapy in neonates for hypotension is 0.5 mg/kg every 6 hours.
Drug: Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Other Names:
  • Solu-Cortef
Active Comparator: Modified dose hydrocortisone
The modified dose of hydrocortisone therapy will be determined based on the pharmacokinetic results.
Drug: Hydrocortisone
intravenous bolus hydrocortisone therapy during hypothermia treatment
Other Names:
  • Solu-Cortef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood pressure increase
Time Frame: 2 hours
5 mmHg increase in mean arterial blood pressure after drug administration
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular management
Time Frame: 72 hours
Length, cumulative and peak dose of inotrope treatment
72 hours
Presence of relative adrenal insufficiency at baseline
Time Frame: Before hydrocortisone administration within max. 72 hours
Low serum cortisol level at baseline
Before hydrocortisone administration within max. 72 hours
MRI outcome
Time Frame: 4-10 days
Brain injury on MRI examinations
4-10 days
Long term neurodevelopmental outcome
Time Frame: 18-42 month
Performance on motor and mental scales of Bayley III scales of infant development
18-42 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiorgan failure
Time Frame: 72 hours
Presence of multiorgan failure during hypothermia
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Kata Kovacs, MD, PhD, Semmelweis University
  • Study Director: Miklós Szabó, MD, PhD, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-Ped-AsphCort 002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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