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15-Second breath test may guide fluid therapy in sick infants

NCT ID NCT04932590

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 tested a simple bedside test—a 15-second pause in breathing—to see if it could predict whether infants in shock would benefit from more fluids. Ten infants under 2 years old on ventilators in intensive care were included. Researchers measured heart function before, during, and after the pause to see if it could guide treatment decisions.

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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

10 people

The number who actually took part.

Started

Dec 2021

Finished

Sep 2023

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 to 2 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: * Newborn and infant \<2 years. * Born at or near term (\> 36 weeks of amenorrhea). * Hospitalized in pediatric and neonatal intensive care. * Requiring the use of invasive mechanical ventilation. * In a state of shock defined by a cardio-circulatory dysfunction associating arterial hypotension, an alteration in organ perfusion, one or more organ dysfunctions or vasopressor's requirement. Clinical signs retained: heart rate ≥ 90th percentile associated with at least one sign of peripheral hypoperfusion represented by a a capillary refill time ≥ 3sec, or the presence of mottling or coldness of the extremities or urine output ≤ 0.5ml / kg / h or disturbance of consciousness. * The practitioner in charge of the patient has decided to perform volume expansion. * Non-opposition expressed by the holders of parental authority. Exclusion Criteria: * Any serious and urgent clinical hemodynamic situation, the management of which would be delayed by inclusion in the protocol. * Patient with unoperated congenital heart disease. * Patient in spontaneous or non-invasive ventilation or with spontaneous ventilatory cycles in invasive ventilation. * Patient in prolonged cardiac arrest (\> 5min) or refractory. * Patient under venous-arterial extracorporeal membrane oxygenation. * Refusal of the holders of parental authority to exploit the collected data.

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Conditions

The condition(s) this trial relates to.

Shock

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hôpital Armand Trousseau

    Paris, 75012, France

More trials for these conditions

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