TerminatedNot Applicable

Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

Stopped: DSMB recommended termination on the basis of poor accrual rate. We will transition to a prospective observational (non-randomized) study design.

United States3 participantsStarted 2017-05-05

Plain-language summary

The purpose of this study is to compare the effectiveness of two treatment strategies--delayed versus immediate surgery-- for children with primary spontaneous pneumothorax (collapse of the lung). Currently, both treatment modalities are used and there is no clear evidence that either option is superior. The investigators hypothesize that immediate surgery will have better outcomes with lower recurrence rates than delayed surgery.

Who can participate

Age range5 Years – 18 Years

SexALL

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: * Children ages 5 to 18 with clinical diagnosis of primary spontaneous pneumothorax (symptoms of chest pain and/or shortness of breath and pneumothorax demonstrated on chest radiograph) and no prior history of pneumothorax Exclusion Criteria: * Blunt or penetrating trauma * Cystic fibrosis * Pneumonia * Uncontrolled asthma with hospitalization for exacerbation within previous 30 days * Congenital cystic adenomatoid malformation or congenital lobar emphysema * History of previous cardiac or pulmonary surgery

What they're measuring

Recurrence rate

Timeframe: 1 month

Recurrence rate

Timeframe: 3 months

Recurrence rate

Timeframe: 6 months

Recurrence rate

Timeframe: 12 months

Trial details

NCT IDNCT02449980

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-26

View on ClinicalTrials.gov More Pneumothorax trials