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The COllaborative Neonatal Network for the First CPAM Trial

NCT05701514 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2024-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Pulmonary Airway Malformation

Interventions

PROCEDURE

Elective surgical resection of CPAM between 6 and 9 months of age

Surgical resection of the CPAM between 6 and 9 months of age

Sponsors & Collaborators

Principal Investigators

  • Rene MH Wijnen, professor · Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2030-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701514 on ClinicalTrials.gov