The COllaborative Neonatal Network for the First CPAM Trial
The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial
Erasmus Medical Center
176 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Lesion detected during routine prenatal ultrasound screening
- Delivery at term: gestational age ≥37 weeks
- Birthweight > -2SD or >P10
- Asymptomatic at birth defined as no prolonged respiratory distress or oxygen support (< 24 hours)
- Asymptomatic up to the moment of inclusion
- Confirmation of CPAM on postnatal chest CT-scan at 3-9 months of age, according to structured report form (34)
- Unilateral lesion occupying no more than one lung lobe as assessed on chest CT-scan at 3-9 months of age
Exclusion Criteria7
- Bilateral lesion
- Development of symptoms before randomization, considered by treating physician as caused by CPAM with reasonable certainty
- Complicated pregnancy defined as (pre-)eclampsia, pregnancy diabetes in mother, foetal hydrops or severe polyhydramnios on prenatal ultrasound
- Syndrome associated anomalies on genetic analysis confirmed by genetic expert
- Major associated malformations. Anomalies include cardiac malformations requiring surgical correction or follow-up by a paediatric cardiologist, congenital malformations requiring major surgical intervention, and anomalies that affect normal lung growth and development.
- Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months
- Participation in another randomised controlled trial
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Surgical resection of the CPAM between 6 and 9 months of age
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05701514