NCT05701514 The COllaborative Neonatal Network for the First CPAM Trial
| NCT ID | NCT05701514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Congenital Pulmonary Airway Malformation |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Rene MH Wijnen, professor
STUDY DIRECTOR
Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam
Frequently Asked Questions
Who can join the NCT05701514 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 1 Year, studying Congenital Pulmonary Airway Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701514 currently recruiting?
Yes, NCT05701514 is actively recruiting participants. Contact the research team at j.schnater@erasmusmc.nl for enrollment information.
Where is the NCT05701514 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT05701514 clinical trial?
NCT05701514 is sponsored by Erasmus Medical Center. The principal investigator is Rene MH Wijnen, professor at Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam. The trial plans to enroll 176 participants.