The COllaborative Neonatal Network for the First CPAM Trial
Recruiting
N/A
Interventional Study
Congenital Pulmonary Airway Malformation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 1 Month – 1
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 176 (estimated)
- Sponsor
- Erasmus Medical Center · Other
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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 s…
Trial Locations
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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 inc…
Contacts