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New study aims to find best breathing support for kids with ARDS

NCT ID NCT07123961

Disease control Sponsor: Children's Hospital of Philadelphia 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 1 time

Summary

This study looks at two different ways to use ventilators for children with acute respiratory distress syndrome (ARDS), a serious lung condition. The goal is to see which method helps children recover faster and breathe better. About 160 children will take part, and the results will help doctors choose the best ventilator settings for kids.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

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

Started

Nov 2025

Expected to finish

Jun 2030

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

2 weeks to 17 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: 1. age \> 2 weeks (\> 38 weeks corrected gestational age) and \< 18 years (not yet had 18th birthday) 2. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation 3. ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset 4. hypoxemia defined as PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) \> 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) \> 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O (rate of pressure delivery) on two consecutive measurements 4 hours apart and sustained at the time of consent and randomization 5. bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI Exclusion: 1. hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload 2. non-palliated or unrepaired cyanotic congenital heart disease 3. ventilated via tracheostomy at baseline prior to acute illness 4. obstructive airway disease determined to be the primary cause of respiratory failure 5. severe moribund state not expected to survive \> 72 hours 6. any limitations of care at time of screening 7. escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening 8. previous enrollment in this study

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome pediatric acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome (ARDS) Lung-protective ventilation Pediatric acute respiratory distress syndrome (pards) Ventilator management

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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