The COllaborative Neonatal Network for the First CPAM Trial

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.

Inclusion Criteria:Lesion detected during routine prenatal ultrasound screeningDelivery at term: gestational age ≥37 weeksBirthweight > -2SD or >P10Asymptomatic at birth defined as no prolonged respiratory distress or oxygen support (< 24 hours)Asymptomatic up to the moment of inclusionConfirmation 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 ageExclusion Criteria:Bilateral lesionDevelopment of symptoms before randomization, considered by treating physician as caused by CPAM with reasonable certaintyComplicated pregnancy defined as (pre-)eclampsia, pregnancy diabetes in mother, foetal hydrops or severe polyhydramnios on prenatal ultrasoundSyndrome associated anomalies on genetic analysis confirmed by genetic expertMajor 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 monthsParticipation in another randomised controlled trial