The COllaborative Neonatal Network for the First CPAM Trial (NCT05701514) | Clinical Trial Compass
RecruitingNot Applicable
The COllaborative Neonatal Network for the First CPAM Trial
Netherlands176 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range1 Month – 1 Year
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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