The COllaborative Neonatal NEtwork for the first CPAM Trial, the CONNECT
- Conditions
- Congenital lung abnormalitylung abnormality10038686
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
- 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
- Unilateral lesion occupying no more than one lung lobe as assessed on chest
CT-scan at 3-9 months of age
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the difference in maximal endurance using the BRUCE<br /><br>treadmill test at five years of age between the surgical and conservative<br /><br>group, measured in minutes and SDS.</p><br>
- Secondary Outcome Measures
Name Time Method