Health TrialsbyHealthPanel

The COllaborative Neonatal Network for the First CPAM Trial

ConditionCongenital Pulmonary Airway Malformation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

176 Participants
are divided into 2 treatment groups
Group A: Conservative armNo intervention 0 interventions
Group B: Surgical armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise tolerance

BRUCE treadmill test protocol. Total endurance time will be converted to a sex and age matched percentile score based on pre-defined reference values.

Time frame
5 years

Secondary outcomes

1

Pulmonary morbidity during follow-up

Infection, cough, dyspea, respiratory insufficiency etc.

Time frame
through study completion, a total of 5 years
2

Surgical intervention due to pulmonary morbidity

Indication for surgical resection of the pulmonary lesion following the development of pulmonary morbidity during follow-up

Time frame
Through study completion, a total of 5 years
3

CPAM characteristics on prenatal ultrasound images, according to standardized structured report

Structured report form to be added up to 1 score, in which case a higher score indicates a larger and more complicated lesion

Time frame
20 weeks gestation
4

CPAM characteristics on postnatal CT-scan, according to standardized structured report

Structured report form to be added up to 1 score, in which case a higher score indicates a larger and more complicated lesion

Time frame
3-9 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now