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 range
1 Month – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.