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Tiny bladders, big clues: study seeks best way to measure pressure in newborns

NCT ID NCT01296724

Knowledge-focused Sponsor: Rennes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how to accurately measure pressure inside the bladder of newborns in intensive care. Doctors need to know the right amount of fluid to use for reliable readings, especially in very small babies. The goal is to improve early detection of abdominal compartment syndrome, a serious condition where pressure builds up in the belly and can damage organs. Researchers will test different fluid volumes in babies with and without digestive problems to find the best method.

What this could mean

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

What this could lead to
If successful, this could establish a standard method for measuring abdominal pressure in newborns, helping doctors detect dangerous abdominal compartment syndrome earlier.
What could go wrong
This is a small, early-stage observational study focused on measurement technique, not treatment. Results may not apply to all newborns or lead directly to improved 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

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

54 people

The number who actually took part.

Start date

Feb 2011

Finished

Jul 2013

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

0 days to 3 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: * Preterm or term newborn admitted in paediatric intensive care unit * With an urethral catheter * Consent signed by parents Exclusion Criteria: * Weight \> 4.5 kg * Urinary tract or bladder pathology

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As listed by the trial registrant

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

Intensive care unit syndrome

Contacts and locations

Locations

  • Rennes University Hospital

    Rennes, Brittany Region, 35203, France

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