Comparing surgery to watchful waiting for asymptomatic congenital pulmonary airway malformation in children
Official title: The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial
Run by Erasmus Medical Center · NCT05701514 · Data updated 2026-11-12
This study is testing whether surgery or just keeping an eye on children with asymptomatic congenital pulmonary airway malformation works better for their health and quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 1 Year |
| Sex | All |
| Enrollment | 176 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Nijmegen, Gelderlanf and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2030 |
| Registry record updated | March 4, 2024 |
| Trial ID | NCT05701514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants diagnosed with unilateral asymptomatic CPAM detected during prenatal ultrasound and confirmed by postnatal chest CT.
✕Probably not a fit
Patients with bilateral lesions or those who develop symptoms before randomization may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of conservative management versus elective surgical intervention for children diagnosed with asymptomatic Congenital Pulmonary Airway Malformation (CPAM). Participants will be randomly assigned to either undergo surgical resection of the CPAM between 6 and 9 months of age or to be monitored conservatively. The study will follow both groups for five years, assessing outcomes such as endurance, parental anxiety, quality of life, and pulmonary health. The trial involves multiple centers within the Collaborative Neonatal Network for the first European CPAM Trial consortium.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal management of asymptomatic CPAM, potentially reducing unnecessary surgeries.
How similar studies have gone: Other studies have explored management strategies for CPAM, but this specific randomized approach comparing conservative and surgical options is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Erasmus MC Sophia Children's Hospital
Rotterdam, South Holland, Netherlands Recruiting -
Radboud University Medical Centre
Nijmegen, Gelderlanf, Netherlands Not yet recruiting
Study contacts
- Study coordinator: J Marco Schnater, MD, PhD
- Email: j.schnater@erasmusmc.nl
- Phone: 0031 107036923
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.