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Premie steroid study: could a common drug raise blood pressure years later?

NCT ID NCT05451264

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows up on 52 children, now aged 7 to 13, who were born very prematurely and received either hydrocortisone or a placebo in the PREMILOC trial. Researchers are measuring their blood pressure, pulse wave velocity, and other heart-related markers to see if the steroid affected their cardiovascular health. The goal is to understand long-term risks, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydrocortisone
What this could lead to
If it works, this could help doctors understand whether hydrocortisone given to premature babies raises their risk of high blood pressure later in life.
What could go wrong
This is a small, observational follow-up study, not a new treatment trial. It can only show a link, not prove cause and effect, and results may not apply to all premature infants.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

Jan 2023

Finished

Jul 2024

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

7 to 13 years

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: * Child included in the PREMILOC trial on the Robert Debré site * Age from 7 to 13 years old (eve of 14 years old) * Consent of the holders of parental authority and agreement of the child Exclusion Criteria: * Absence of affiliation to a social security scheme * Patient under state medical aid

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Conditions

The condition(s) this trial relates to.

Infant, Premature, Diseases

As listed by the trial registrant

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

Infant, premature, diseases

Contacts and locations

Locations

  • Robert Debre Hospital

    Paris, 75019, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.