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New monitoring method may improve safety for infant skull surgery

NCT ID NCT06263075

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30 infants (3-8 months old) having surgery for craniosynostosis, a condition where skull bones fuse too early. Researchers want to see if a new monitoring method (PRAM) can better track blood pressure and fluid loss than standard monitors. The goal is to improve safety during these high-risk surgeries.

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.

Participants

About 30 people

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

Started

Dec 2023

Expected to finish

Jun 2026

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.

Who is studied

Consecutive infants aged 3 to 8 months with craniosynostosis admitted to the operating room of IRCCS AOU of Bologna Polyclinic Sant'Orsola to undergo corrective surgery.

Ages

3 to 8 months

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: * Infants with craniosynostosis undergoing corrective surgery * Ages between 3 and 8 months * Physical status classification of the American Society of Anesthesiologists (ASA) \</= 2 * Consent obtained from the patients' parents/legal guardians Exclusion Criteria: * Congenital or acquired cardiac disease * Preoperative cardiac dysfunction * Metabolic diseases * Gestational age at birth \<30 weeks * Body weight less than 3 kg * Dislocation or malfunction of the arterial catheter * Malfunctioning of monitoring devices

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Conditions

The condition(s) this trial relates to.

craniosynostosis Hemorrhage Hypovolemia

As listed by the trial registrant

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

Craniosynostoses Hemodynamic instability Hemorrhage Hypovolemia

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

  • IRCCS AOU of Bologna Policlinico Sant'Orsola

    RECRUITING

    Bologna, BO, 40138, Italy

More trials for these conditions

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