Acute Respiratory Distress Syndrome (ARDS)Phase 2PARMANCT07123961

Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial

A Phase 2 study testing High Driving Pressure Mechanical Ventilation and Low Driving Pressure Mechanical Ventilation in people with Acute Respiratory Distress Syndrome (ARDS) and Ventilator Management, run by Children's Hospital of Philadelphia at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 2 weeks to 17 years
Conditions the study is for: Acute Respiratory Distress Syndrome (ARDS), Ventilator Management, Lung-protective Ventilation
What is being tested?: High Driving Pressure Mechanical Ventilation and Low Driving Pressure Mechanical Ventilation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2025to 30 Jun 2030
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 weeks to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

age > 2 weeks (> 38 weeks corrected gestational age) and < 18 years (not yet had 18th birthday)
acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset
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
bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI

Who cannot join

hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
non-palliated or unrepaired cyanotic congenital heart disease
ventilated via tracheostomy at baseline prior to acute illness
obstructive airway disease determined to be the primary cause of respiratory failure
severe moribund state not expected to survive > 72 hours
any limitations of care at time of screening
escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening
previous enrollment in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial

Acute respiratory distress syndrome (ARDS) is a serious and potentially life-threatening lung condition that can affect children. Currently, ventilator settings commonly used in treatment are based on approaches developed for adults, and it remains unclear whether these settings are equally effective for children. Because children's bodies respond differently than adults', it is important to determine the most effective ventilator strategies specifically for pediatric patients. This study will compare two different ventilator approaches in children with ARDS to identify which method provides the greatest benefit. The findings will also help inform the design of a larger study in the future.

Conditions: Acute Respiratory Distress Syndrome (ARDS), Ventilator Management, Lung-protective Ventilation, Pediatric Acute Respiratory Distress Syndrome (PARDS)
Being tested: High Driving Pressure Mechanical Ventilation, Low Driving Pressure Mechanical Ventilation
Keywords: Acute Respiratory Distress Syndrome, ARDS, Vent, Ventilator, Ventilator Management, Pediatric ARDS, Pediatric Ventilator Management, PARDS, Pediatric ARDS Protocolized Treatment, Invasive Mechanical Ventilation, IMV, Pediatric Acute Respiratory Distress Syndrome
Medical subject headings: Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Driving Pressure Mechanical VentilationOther
A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Dräger, Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 25 cmH2O (rate of pressure delivery). The Children's Hospital of Philadelphia (CHOP) PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 Electrical Impedance Tomography (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.
Low Driving Pressure Mechanical VentilationOther
A participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 15 cmH2O (rate of pressure delivery). CHOP PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.

Study groups in NCT07123961
Study group	Role	What they receive
High Driving Pressure Mechanical Ventilation	Active comparator	A participant who is already on the breathing machine will have the driving pressure set to 25 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do. Receives: Other: High Driving Pressure Mechanical Ventilation
Low Driving Pressure Mechanical Ventilation	Active comparator	A participant who is already on the breathing machine will have the driving pressure set to 15 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do. Receives: Other: Low Driving Pressure Mechanical Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

Sustained Resolution of Hypoxemia
The primary outcome of PARMA is time (in hours) per participant to sustained resolution of hypoxemia, defined as being alive with 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 two consecutive measurements 4 hours apart. This outcome is censored at 28 days (672 hours).
Measured: Up to 672 hours

Secondary outcomes (14)

Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment
EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with recruited lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined.
Measured: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Imaging (Electrical Impedance Tomography (EIT)): Overdistension
EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The percentage of patients with overdistended lung at the immediate post-randomization EIT, relative to pre-randomization EIT measurement will be determined.
Measured: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Imaging (Electrical Impedance Tomography (EIT)): Center of Ventilation
EIT (Electronic Impedance Tomography) is an FDA-approved non-radiating method of imaging lung aeration. EIT bands are placed on the subject and EIT imaging will be performed at three time points to assess the assigned study arm. The average value of center of ventilation for each study arm at the immediate post-randomization EIT will be compared.
Measured: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Clinical End Point: all-cause mortality at 90 days
Total number of participants all-cause mortality at 90 days after enrollment or hospital discharge.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: all-cause mortality at 28 days
Total number of participants all-cause mortality at 28 days after enrollment or hospital discharge.
Measured: From enrollment up to hospital discharge, no longer than 28 days.
Clinical End Point: Pediatric ICU discharge
Total days per participant until Pediatric ICU discharge from start of enrollment.
Measured: From enrollment up to pediatric ICU discharge, no longer than 90 days
Clinical End Point: Hospital Discharge
Total days per participant until hospital discharge from enrollment.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: Primary Cause of Death
Total number of participants who meet primary cause of death as defined as brain death, other neurologic, multiple organ dysfunction syndrome, refractory shock, refractory hemorrhage or refractory hypoxemia.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: Ventilator Free Days
Total ventilator free days (VFDs) per participant at 28 days (defined as number of days alive and off invasive ventilation by day 28).
Measured: From enrollment up to hospital discharge, no longer than 28 days.
Clinical End Point: New Oxygenation- or Ventilator-dependency
Total number of participants with new oxygenation- or ventilator-dependency at time of discharge.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: pneumothorax requiring chest tube
Total number of participants with diagnosis of pneumothorax requiring chest tube.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: other air leak not requiring chest tube
Total number of participants with diagnosis of other air leak not requiring chest tubes.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: ventilator-associated pneumonia
Total number of participants with diagnosis of ventilator-associated pneumonia.
Measured: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: new or progressive multiple organ dysfunction syndrome
Total number of participants with diagnosis of new or progressive multiple organ dysfunction syndrome.
Measured: From enrollment up to hospital discharge, no longer than 90 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 202530 Jun 2030

First posted14 Aug 2025
Study start7 Nov 2025
Primary completion31 Dec 2029 (estimated)
Study completion30 Jun 2030 (estimated)

Why it stopped: Suspended for review and amendments to study documents.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible and consented subjects will be randomized within 24 hours of meeting study eligibility using 1:1 permuted blocks, using a randomization module available in Research Electronic Data CAPture (REDCap).
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07123961
Sponsor's protocol ID: 24-022470
Acronym: PARMA
Status last verified: Aug 2026
First submitted: 6 Aug 2025
Last updated: 14 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified trial dataset, stripped of all personal health information, will be shared with an existing NIH data repository (likely the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Respiratory Distress Syndrome (ARDS) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial
ClinicalTrials.gov ID: NCT07123961
Acronym / sponsor ID: PARMA / 24-022470
Conditions: Acute Respiratory Distress Syndrome (ARDS), Ventilator Management, Lung-protective Ventilation, Pediatric Acute Respiratory Distress Syndrome (PARDS)
Keywords: Acute Respiratory Distress Syndrome, ARDS, Vent, Ventilator, Ventilator Management, Pediatric ARDS, Pediatric Ventilator Management, PARDS
Phase: Phase 2
Study type: Interventional
Recruitment status: SuspendedReason stopped: Suspended for review and amendments to study documents.
Enrolment: 160 participants (estimated)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: University of Pennsylvania
Study start: 7 Nov 2025 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 30 Jun 2030 (estimated)
First posted: 14 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Eligible and consented subjects will be randomized within 24 hours of meeting study eligibility using 1:1 permuted blocks, using a randomization module available in Research Electronic Data CAPture (REDCap).

Arm	Type	Receives
High Driving Pressure Mechanical Ventilation	Active comparator	Other: High Driving Pressure Mechanical VentilationA participant who is already on the breathing machine will have the driving pressure set to 25 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.
Low Driving Pressure Mechanical Ventilation	Active comparator	Other: Low Driving Pressure Mechanical VentilationA participant who is already on the breathing machine will have the driving pressure set to 15 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.

Who may qualify

Ages: 2 weeks to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

age > 2 weeks (> 38 weeks corrected gestational age) and < 18 years (not yet had 18th birthday)
acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset
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
bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI

Key exclusion criteria (8 listed)

hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
non-palliated or unrepaired cyanotic congenital heart disease
ventilated via tracheostomy at baseline prior to acute illness
obstructive airway disease determined to be the primary cause of respiratory failure
severe moribund state not expected to survive > 72 hours

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Driving Pressure Mechanical VentilationA participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Dräger, Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 25 cmH2O (rate of pressure delivery). The Children's Hospital of Philadelphia (CHOP) PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 Electrical Impedance Tomography (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.	Other	High Driving Pressure Mechanical Ventilation
Low Driving Pressure Mechanical VentilationA participant who is already invasively mechanically ventilated will be placed on "Pressure Control Ventilation" mode on an Evita V500 (Manufacturer: Lübeck, Germany) ventilator if they are not already. The driving pressure will be set to 15 cmH2O (rate of pressure delivery). CHOP PICU's standard of care regarding sedation, fluid management, ventilator weaning, and extubation readiness for invasively mechanically ventilated children will be adhered to for the duration of the study. An Enlight 2100 (EIT) Device (Manufacturer: Timpel) strap will be placed across the participant's chest up to four times throughout the study for a few hours to image the aeration in the lungs.	Other	Low Driving Pressure Mechanical Ventilation

Primary outcome

Sustained Resolution of Hypoxemia
Time frame: Up to 672 hours
The primary outcome of PARMA is time (in hours) per participant to sustained resolution of hypoxemia, defined as being alive with 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 two consecutive measurements 4 hours apart. This outcome is censored at 28 days (672 hours).

14 secondary outcomes

Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment
Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Imaging (Electrical Impedance Tomography (EIT)): Overdistension
Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Imaging (Electrical Impedance Tomography (EIT)): Center of Ventilation
Time frame: Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.
Clinical End Point: all-cause mortality at 90 days
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: all-cause mortality at 28 days
Time frame: From enrollment up to hospital discharge, no longer than 28 days.
Clinical End Point: Pediatric ICU discharge
Time frame: From enrollment up to pediatric ICU discharge, no longer than 90 days
Clinical End Point: Hospital Discharge
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: Primary Cause of Death
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Clinical End Point: Ventilator Free Days
Time frame: From enrollment up to hospital discharge, no longer than 28 days.
Clinical End Point: New Oxygenation- or Ventilator-dependency
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: pneumothorax requiring chest tube
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: other air leak not requiring chest tube
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: ventilator-associated pneumonia
Time frame: From enrollment up to hospital discharge, no longer than 90 days.
Safety Endpoint: new or progressive multiple organ dysfunction syndrome
Time frame: From enrollment up to hospital discharge, no longer than 90 days.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
Individual participant dataSharing planned: Yes. De-identified trial dataset, stripped of all personal health information, will be shared with an existing NIH data repository (likely the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nadir Yehya, MD, MSCE principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Resolution of Hypoxemia (time frame: Up to 672 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07123961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.