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Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

NCT02449980 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-11-06

No results posted yet for this study

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.

Conditions

  • Pneumothorax

Interventions

PROCEDURE

Primary Surgery Group

Patients will receive surgical intervention during the initial hospital admission, as previously described, for the spontaneous pneumothorax. Patients will then be admitted postoperatively and monitored until discharge criteria are met

PROCEDURE

Initial Non-operative management

Patients will receive percutaneous drainage or chest tube placement as initial management for spontaneous pneumothorax. This will be followed by an observation period until discharge criteria are met.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Monica E Lopez, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2018-07-26
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02449980 on ClinicalTrials.gov