Spontaneous Pneumothorax in Children (NCT02573285) | Clinical Trial Compass
CompletedNot Applicable
Spontaneous Pneumothorax in Children
United States37 participantsStarted 2016-03-10
Plain-language summary
The objective of this multi-center, non-randomized, prospective pilot study is to examine the rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple aspiration technique.
In this study, eligible subjects diagnosed with PSP at eleven participating large children's hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be enrolled and offered a choice of management with either the simple aspiration protocol or management according to their surgeon's preference, which may include simple aspiration, chest tube placement, or rarely, an operation.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age greater than or equal to 12 years and less than 18 years at date of enrollment.
. First time seeking medical attention for symptoms related to primary spontaneous pneumothorax.
. Consulting surgeon determines that intervention is required for treatment of spontaneous pneumothorax.
Exclusion criteria
. Patients with a previous episode of pneumothorax on the same side of the chest that required medical treatment in the past.
. Pneumothorax is secondary to a co-morbid medical condition (underlying pulmonary disease, malignancy, or trauma).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The success rate of simple aspiration of initial management of primary spontaneous pneumothorax in children
Timeframe: At the time of post-procedure chest X-ray
. Pneumothorax is small and amenable to observation: size \<2cm space between lung and chest wall at the apex and clinically stable patient with minimal symptoms.
. Bilateral pneumothorax.
. Unstable patient in need of emergent intervention at surgeon discretion.