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The COllaborative Neonatal Network for the First CPAM Trial
Sponsor: Erasmus Medical Center
Summary
The goal of this clinical trial is to compare conservative wait-and-see management to elective surgical intervention, in asymptomatic Congenital Pulmonary Airway Malformation (CPAM) children. Children assigned to the intervention group will undergo surgical resection of the CPAM between 6 and 9 months of age. Children assigned to the control group will be monitored conservatively. The follow-up scheme will be uniform for both treatment groups and last for 5 years. The primary outcome is the difference in maximal endurance at five years of age between the surgical and conservative group. Secondary outcome measures are molecular genetic diagnostics, validated questionnaires - on parental anxiety, quality of life and health care consumption -, repeated imaging, and pulmonary morbidity during follow-up, as well as surgical complications and histopathology.
Official title: The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial
Key Details
Gender
All
Age Range
1 Month - 1 Year
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2023-01-01
Completion Date
2030-12-31
Last Updated
2024-03-04
Healthy Volunteers
No
Conditions
Interventions
Elective surgical resection of CPAM between 6 and 9 months of age
Surgical resection of the CPAM between 6 and 9 months of age
Locations (2)
Radboud University Medical Centre
Nijmegen, Gelderlanf, Netherlands
Erasmus MC Sophia Children's Hospital
Rotterdam, South Holland, Netherlands