NCT07123961 Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial
| NCT ID | NCT07123961 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-11-07 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Nadir Yehya, MD, MSCE
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT07123961 clinical trial?
This trial is open to participants of all sexes, aged 2 Weeks or older, up to 17 Years, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07123961 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07123961 currently recruiting?
Yes, NCT07123961 is actively recruiting participants. Contact the research team at wiatrowskh@chop.edu for enrollment information.
Where is the NCT07123961 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07123961 clinical trial?
NCT07123961 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Nadir Yehya, MD, MSCE at Children's Hospital of Philadelphia. The trial plans to enroll 160 participants.