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New treatment option for Congenital Pulmonary Airway Malformation
Official title The COllaborative Neonatal Network for the First CPAM Trial
ClinicalTrials.gov ID: NCT05701514
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 1
You may be able to join if
- 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
You likely can't join if
- 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...
- Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months
See the full eligibility 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
- 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...
- Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months
- Participation in another assigned by chance controlled trial
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderlanf, Netherlands
- Rotterdam, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderlanf, Netherlands; Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.