The COllaborative Neonatal Network for the First CPAM Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorErasmus Medical Center
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Elective surgical resection of CPAM between 6 and 9 months of age
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov