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Cooled newborns get tailored steroid dosing to stabilize blood pressure

NCT ID NCT05836610

Symptom relief Sponsor: Semmelweis University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at giving hydrocortisone, a steroid, to newborns with brain injury from lack of oxygen who are being cooled and have low blood pressure. Researchers want to find the best dose for each baby by measuring steroid levels in the blood. The goal is to safely raise blood pressure and improve long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 72 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Asphyxia brain hypoxia - ischemia hypotensive disorder perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asphyxia Circulatory failure neonatal Hypotension Hypoxic-ischemic encephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Semmelweis University Department of Pediatrics (Bókay street Unit)

    RECRUITING

    Budapest, Pest County, 1083, Hungary

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