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New treatment option for Acute Respiratory Distress Syndrome (ARDS)
Official title Pediatric Acute Respiratory Distress Syndrome (ARDS) Management Trial
ClinicalTrials.gov ID: NCT07123961
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Inclusion:
- 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...
See the full eligibility criteria
- Inclusion:
- 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...
- bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI Exclusion:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 weeks to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.