Actively Recruiting
The COllaborative Neonatal Network for the First CPAM Trial
Led by Erasmus Medical Center · Updated on 2024-03-04
176
Participants Needed
2
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The COllaborative Neonatal Network for the First CPAM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lesion detected during routine prenatal ultrasound screening
- Delivery at term: gestational age 6537 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
- Unilateral lesion occupying no more than one lung lobe as assessed on chest CT-scan at 3-9 months of age
You will not qualify if you...
- 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, including cardiac malformations requiring surgery or follow-up, congenital malformations needing major surgery, and anomalies affecting normal lung growth
- Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months
- Participation in another randomised controlled trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Radboud University Medical Centre
Nijmegen, Gelderlanf, Netherlands, 6525GA
Not Yet Recruiting
2
Erasmus MC Sophia Children's Hospital
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
J
J Marco Schnater, MD, PhD
CONTACT
R
Rene MH Wijnen, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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