The COllaborative Neonatal NEtwork for the first CPAM Trial, the CONNECT - CONNECT trial

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•\- 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.