Congenital lung abnormality lung abnormality
Conditions
Interventions
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 fo
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 11 Years
Inclusion 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 (
Exclusion criteria
Exclusion criteria: - 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. - Suspicion of malignancy on chest CT scan evaluation at the age of 3-9 months - Participation in another randomised controlled trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the difference in maximal endurance using the BRUCE treadmill test at five years of age between the surgical and conservative group, measured in minutes and SDS. | — |
Secondary
| Measure | Time frame |
|---|---|
| o Pulmonary morbidity during follow-up (occurrence of infections, cough, dyspnoea, respiratory insufficiency and other pulmonary symptoms). o Frequency of surgical intervention due to pulmonary morbidity during follow-up period o CPAM characteristics on prenatal ultrasound images, reported according to structured report, see Appendix D (35) o CPAM characteristics on CT-scan at 3-9 months of age, reported according to structured report form Appendix C (34) o CPAM development / post-surgical appearance on repeated CT imaging, reported according to structured report form (34) o Parental anxiety, pre-operative and at all follow-up visits by means of the Visual Analogue Scale for Anxiety (VAS-A) (38, 39) o Quality of life analysis by means of the Infant Toddler Quality of Life Questionnaire (ITQOL) (40) o Pathological characteristics of resected material (macroscopic, microscopic, immunohistochemistry, molecular diagnostics) as assessed by local pathologist of participating centre according to Appendix B (23) o Abnormal anthropometric measurements during follow-up, measured with help of local SD-score computation o Analysis of the cost-effectiveness of both management strategies and comparison between them, see chapter 10-c | — |
Countries
Netherlands
Outcome results
None listed