COllaborative Neonatal Network for the first European CPAM Trial (CONNECT): a study protocol for a randomised...

Area of Science:

• Pediatric Surgery
• Neonatal Care
• Respiratory Medicine

Background:

• Optimal management for asymptomatic congenital pulmonary airway malformation (CPAM) lacks consensus.
• The CONNECT consortium established a core outcome set for CPAM research.
• This includes parameters for respiratory insufficiency, surgical complications, mass effect, and multifocal disease.

Purpose of the Study:

• To compare conservative versus surgical management for asymptomatic CPAM.
• To develop evidence-based practice guidelines for CPAM treatment.
• To resolve the ongoing debate regarding the best approach for asymptomatic CPAM.

Main Methods:

• A randomized controlled trial (CONNECT trial) comparing conservative and surgical management.
• Inclusion criteria: confirmed CPAM diagnosis on postnatal CT scan, asymptomatic status.
• Standardized 5-year follow-up with clinical visits, imaging, and exercise testing.

Main Results:

• Primary outcome: exercise tolerance at age 5 years (Bruce treadmill protocol).
• Secondary outcomes: molecular diagnostics, validated questionnaires (anxiety, quality of life, healthcare consumption), imaging, pulmonary morbidity, surgical complications, and histopathology.
• Data collection ongoing; results to be disseminated upon completion.

Conclusions:

• The CONNECT trial is designed to provide crucial evidence for managing asymptomatic CPAM.
• Findings will inform clinical decision-making and potentially standardize treatment protocols.
• This research aims to improve long-term outcomes for children with CPAM.