Congenital Pulmonary Airway MalformationCONNECTNCT05701514
The COllaborative Neonatal Network for the First CPAM Trial
A study testing Elective surgical resection of CPAM between 6 and 9 months of age in people with Congenital Pulmonary Airway Malformation, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Congenital Pulmonary Airway Malformation
- What is being tested?
- Elective surgical resection of CPAM between 6 and 9 months of age
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 (34)
- Unilateral lesion occupying no more than one lung lobe as assessed on chest CT-scan at 3-9 months of age
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Radboud University Medical Centre
Nijmegen, Gelderlanf, 6525GA
Maarten Schurink, MD, PhD
- Recruiting
Erasmus MC Sophia Children's Hospital
Rotterdam, South Holland, 3015GD
Marco Schnater, MD, PhD, 0031107036923, j.schnater@erasmusmc.nl
Rene MH Wijnen, Professor, 0031107036923, r.wijnen@erasmusmc.nl
About this study
Official title: The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) 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.
Read the detailed description
Study design: prospective multicentre randomized controlled trial. Duration: the total duration of the follow-up will be 5 years Setting: collaborating centres within the COllaborative Neonatal Network for the first European Congenital Pulmonary Airway Malformation (CPAM) Trial consortium (CONNECT)
Parents expecting a child with a prenatally diagnosed CPAM will be counselled and informed about the study prenatally. At the age of 6 months, each child will undergo a chest CT with intravenous contrast in order to confirm the diagnosis, as part of the standard of care. This chest CT will be evaluated according to a structured report. If the chest CT confirms the diagnosis CPAM and the child remains asymptomatic, the child is eligible for inclusion. After having obtained informed consent from parents or caregivers, randomisation to the surgical arm or the non-surgical arm will take place. At this point, the prenatal ultrasound images will be retrospectively evaluated according to a structured report.
In case of randomisation to the surgical arm, surgical resection will take place between 6 and 9 months of age. The type and extent of the surgical procedure is dependent on the lesion characteristics, local protocol and the surgeon's preference. Preferably, small lesions are treated with a segmentectomy; i.e., sub-lobar resection. Larger lesions are generally treated with lobectomy. Wedge resection is not advised due to higher risks of post-operative air leakage and residual disease. Surgical details will be documented according to a structured report.
Resected material will be sent to the local pathology department for analysis. The local pathologist will analyse the material, and document the results according to the Structured Pathology Report for Congenital Pulmonary Airway Malformation.
Genetic testing will be offered as part of routine diagnostic procedures. Standard information leaflets and informed consent forms of the department of clinical genetics will be offered to parents. If parental consent is obtained, blood (1-4ml, depending on availability/safety) will be drawn from the study subject, at the moment when an IV-needle is placed - in order to administer the IV-contrast - just before the diagnostic CT-scan). This material will be stored in a plastic Etheylenediaminetetraacetic acid (EDTA) vacutainer blood collector tube. Similarly, blood of both parents - if possible - (10 ml) will be drawn and stored in a plastic EDTA vacutainer blood collector tube. These parental samples will be sent for DNA isolation and genetic analysis to the local departments of Clinical Genetics, where the DNA will be stored. In this diagnostic procedure, trio single nucleotide polymorphism (SNP) array / whole exome sequencing or whole genome sequencing will be performed.
The follow-up program lasts 5 years, is uniform for all patients and consists of three assessments at the ages of 1 year, 2.5 years, and 5 years (with a margin of 2 months towards the patients' age for each assessment). This follow-up structure is standard of care in the majority of the participating centres. Patients assigned to the surgical arm will visit the hospital one additional time, 2-6 weeks after the surgery has taken place, for scar inspection, postoperative complaints and evaluation of the pathology report. At the second visit (at 2.5 years) a follow-up CT-scan will be performed, and during the last visit participants will perform a standardised exercise test using the BRUCE treadmill protocol, supervised by a certified paediatric physical therapist.
Furthermore, parents will be asked to complete several questionnaires, addressing anxiety, quality of life and medical costs.
The duration of the follow-up was set to 5 years to ensure enough time to observe potential differences in clinical outcome between the two study groups (i.e., the development of post-surgical complications or the development of symptoms in the conservative group). Another consideration was that the age of 5 years is the youngest age at which standardised endurance tests have been validated.
- Conditions
- Congenital Pulmonary Airway Malformation
- Being tested
- Elective surgical resection of CPAM between 6 and 9 months of age
- Keywords
- Asymptomatic CPAM, Optimal management, Conservative vs surgical, Randomized
- Medical subject headings
- Cystic Adenomatoid Malformation of Lung, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgical resection of CPAM between 6 and 9 months of ageProcedure or surgery
Surgical resection of the CPAM between 6 and 9 months of age
| Study group | Role | What they receive |
|---|---|---|
| Conservative arm | No intervention | Children assigned to this treatment arm will be conservatively managed, and will continue to be followed until the age of 5 years (end of study inclusion). |
| Surgical arm | Active comparator | Children assigned to this treatment arm will undergo elective surgical resection at the age of 6-9 months, and will continue to be followed until the age of 5 years (end of study inclusion). Receives: Procedure: Elective surgical resection of CPAM between 6 and 9 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (13)
Pulmonary morbidity during follow-up
Infection, cough, dyspea, respiratory insufficiency etc.
Measured: through study completion, a total of 5 years
Surgical intervention due to pulmonary morbidity
Indication for surgical resection of the pulmonary lesion following the development of pulmonary morbidity during follow-up
Measured: Through study completion, a total of 5 years
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
Measured: 20 weeks gestation
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
Measured: 3-9 months of age
CPAM development / post-surgical appearance on repeated CT imaging, 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
Measured: 2.5 years of age
CPAM development / post-surgical appearance on CT imaging - scored according to the Congenital Lung Abnormalities Quantification (CLAQ) method
Structured report form to be added up to 1 score, in which case a higher score indicates a larger and more complicated lesion
Measured: 3-9 months of age + 2.5 years of age
Quality of life analysis
Toddler Quality of Life Questionnaire (ITQOL), transformed to a scale score from 0 (worst health) to 100 (best health)
Measured: 6 months, 1 year, 2.5 years, 5 years
Quality of life analysis
Child Health Utility Index (CHU9D). Translated to total raw scores ranging from 0 (no impairment) to 36 (maximal impairment) based 9 questions in 9 different dimensions.
Measured: 5 years
Parental anxiety level, assessed pre-operatively
Visual Analogue Scale for Anxiety (VAS-A), scored from 0 (no anxiety) to 10 (maximal anxiety).
Measured: 6 months, 1 year, 2.5 years, 5 years
Weight
Converted to Standard Deviation score
Measured: 6 months, 1 year, 2.5 years, 5 years
Height
Converted to Standard Deviation score
Measured: 6 months, 1 year, 2.5 years, 5 years
Pathological characteristics of resected material, according to standardized structured report
Structured report form to be added up to 1 score, in which case this score defines specific, pre-defined pathological lesion characteristics. This score does therefore not indicate better of worse, but rather specifies the lesion characteristics.
Measured: 9-12 months
Cost-effectiveness of both management strategies and comparison
The cost consequences and cost-effectiveness of surgical versus conservative management of CPAM will be analyzed through a trial-based economic evaluation.
Data on health care resource consumption will be extracted from both the electronic information systems of the participating centres and the Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ).
As regards the effects of the intervention, the economic evaluation will look at maximal endurance time and quality-adjusted life-years (QALYs), which is a measure of health outcome that combines quality of life with length of life. The calculation of QALYs will be based on survival data and on responses to the Child Health Utility 9D (CHU9D) questionnaire
Measured: 6 months, 1 year, 2.5 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Pulmonary Airway MalformationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, multicentre superiority trial. Randomisation will take place as blocked randomisation with stratification by centre, with a 1:1 allocation.
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. J Marco Schnater, Erasmus Medical Center
- Investigators
- Rene MH Wijnen, professor, Study director, Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701514
- Sponsor's protocol ID
- CONNECT-study
- Acronym
- CONNECT
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Hermelijn S, Kersten C, Mullassery D, Muthialu N, Cobanoglu N, Gartner S, Bagolan P, Mesas Burgos C, Sgro A, Heyman S, Till H, Suominen J, Schurink M, Desender L, Losty P, Ertresvag K, Tiddens HAWM, Wijnen RMH, Schnater M; CONNECT study consortium COS development group; CONNECT study consortium COS development group. Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey. BMJ Open. 2021 Apr 12;11(4):e044544. doi: 10.1136/bmjopen-2020-044544.
PubMed 33846152Kersten CM, Hermelijn SM, Mullassery D, Muthialu N, Cobanoglu N, Gartner S, Bagolan P, Mesas Burgos C, Sgro A, Heyman S, Till H, Suominen J, Schurink M, Desender L, Losty P, Steyaert H, Terheggen-Lagro S, Metzelder M, Bonnard A, Sfeir R, Singh M, Yardley I, Rikkers-Mutsaerts NRVM, van der Ent CK, Qvist N, Cox DW, Peters R, Bannier MAGE, Wessel L, Proesmans M, Stanton M, Hannon E, Zampoli M, Morini F, Tiddens HAWM, Wijnen RMH, Schnater JM. The Management of Asymptomatic Congenital Pulmonary Airway Malformation: Results of a European Delphi Survey. Children (Basel). 2022 Jul 30;9(8):1153. doi: 10.3390/children9081153.
PubMed 36010044Kersten CM, Hermelijn SM, Dossche LWJ, Muthialu N, Losty PD, Schurink M, Rietman AB, Poley MJ, van Rosmalen J, Zanen-van den Adel TPL, Ciet P, von der Thusen J, Brosens E, Ijsselstijn H, Tiddens HAWM, Wijnen RMH, Schnater JM. COllaborative Neonatal Network for the first European CPAM Trial (CONNECT): a study protocol for a randomised controlled trial. BMJ Open. 2023 Mar 17;13(3):e071989. doi: 10.1136/bmjopen-2023-071989.
PubMed 36931672
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COllaborative Neonatal Network for the First Congenital Pulmonary Airway Malformation (CPAM) Trial
- ClinicalTrials.gov ID
- NCT05701514
- Acronym / sponsor ID
- CONNECT / CONNECT-study
- Conditions
- Congenital Pulmonary Airway Malformation
- Keywords
- Asymptomatic CPAM, Optimal management, Conservative vs surgical, Randomized
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: prospective multicentre randomized controlled trial. Duration: the total duration of the follow-up will be 5 years Setting: collaborating centres within the COllaborative Neonatal Network for the first European Congenital Pulmonary Airway Malformation (CPAM) Trial consortium (CONNECT)
Parents expecting a child with a prenatally diagnosed CPAM will be counselled and informed about the study prenatally. At the age of 6 months, each child will undergo a chest CT with intravenous contrast in order to confirm the diagnosis, as part of the standard of care. This chest CT will be evaluated according to a structured report. If the chest CT confirms the diagnosis CPAM and the child remains asymptomatic, the child is eligible for inclusion. After having obtained informed consent from parents or caregivers, randomisation to the surgical arm or the non-surgical arm will take place. At this point, the prenatal ultrasound images will be retrospectively evaluated according to a structured report.
In case of randomisation to the surgical arm, surgical resection will take place between 6 and 9 months of age. The type and extent of the surgical procedure is dependent on the lesion characteristics, local protocol and the surgeon's preference. Preferably, small lesions are treated with a segmentectomy; i.e., sub-lobar resection. Larger lesions are generally treated with lobectomy. Wedge resection is not advised due to higher risks of post-operative air leakage and residual disease. Surgical details will be documented according to a structured report.
Resected material will be sent to the local pathology department for analysis. The local pathologist will analyse the material, and document the results according to the Structured Pathology Report for Congenital Pulmonary Airway Malformation.
Genetic testing will be offered as part of routine diagnostic procedures. Standard information leaflets and informed consent forms of the department of clinical genetics will be offered to parents. If parental consent is obtained, blood (1-4ml, depending on availability/safety) will be drawn from the study subject, at the moment when an IV-needle is placed - in order to administer the IV-contrast - just before the diagnostic CT-scan). This material will be stored in a plastic Etheylenediaminetetraacetic acid (EDTA) vacutainer blood collector tube. Similarly, blood of both parents - if possible - (10 ml) will be drawn and stored in a plastic EDTA vacutainer blood collector tube. These parental samples will be sent for DNA isolation and genetic analysis to the local departments of Clinical Genetics, where the DNA will be stored. In this diagnostic procedure, trio single nucleotide polymorphism (SNP) array / whole exome sequencing or whole genome sequencing will be performed.
The follow-up program lasts 5 years, is uniform for all patients and consists of three assessments at the ages of 1 year, 2.5 years, and 5 years (with a margin of 2 months towards the patients' age for each assessment). This follow-up structure is standard of care in the majority of the participating centres. Patients assigned to the surgical arm will visit the hospital one additional time, 2-6 weeks after the surgery has taken place, for scar inspection, postoperative complaints and evaluation of the pathology report. At the second visit (at 2.5 years) a follow-up CT-scan will be performed, and during the last visit participants will perform a standardised exercise test using the BRUCE treadmill protocol, supervised by a certified paediatric physical therapist.
Furthermore, parents will be asked to complete several questionnaires, addressing anxiety, quality of life and medical costs.
The duration of the follow-up was set to 5 years to ensure enough time to observe potential differences in clinical outcome between the two study groups (i.e., the development of post-surgical complications or the development of symptoms in the conservative group). Another consideration was that the age of 5 years is the youngest age at which standardised endurance tests have been validated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, controlled, multicentre superiority trial. Randomisation will take place as blocked randomisation with stratification by centre, with a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Conservative arm | No intervention | –Children assigned to this treatment arm will be conservatively managed, and will continue to be followed until the age of 5 years (end of study inclusion). |
| Surgical arm | Active comparator | Procedure: Elective surgical resection of CPAM between 6 and 9 months of ageChildren assigned to this treatment arm will undergo elective surgical resection at the age of 6-9 months, and will continue to be followed until the age of 5 years (end of study inclusion). |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective surgical resection of CPAM between 6 and 9 months of ageSurgical resection of the CPAM between 6 and 9 months of age | Procedure or surgery | Surgical arm |
Primary outcome
Exercise tolerance
Time frame: 5 years
BRUCE treadmill test protocol. Total endurance time will be converted to a sex and age matched percentile score based on pre-defined reference values.
13 secondary outcomes
Pulmonary morbidity during follow-up
Time frame: through study completion, a total of 5 years
Surgical intervention due to pulmonary morbidity
Time frame: Through study completion, a total of 5 years
CPAM characteristics on prenatal ultrasound images, according to standardized structured report
Time frame: 20 weeks gestation
CPAM characteristics on postnatal CT-scan, according to standardized structured report
Time frame: 3-9 months of age
CPAM development / post-surgical appearance on repeated CT imaging, according to standardized structured report
Time frame: 2.5 years of age
CPAM development / post-surgical appearance on CT imaging - scored according to the Congenital Lung Abnormalities Quantification (CLAQ) method
Time frame: 3-9 months of age + 2.5 years of age
Quality of life analysis
Time frame: 6 months, 1 year, 2.5 years, 5 years
Quality of life analysis
Time frame: 5 years
Parental anxiety level, assessed pre-operatively
Time frame: 6 months, 1 year, 2.5 years, 5 years
Weight
Time frame: 6 months, 1 year, 2.5 years, 5 years
Height
Time frame: 6 months, 1 year, 2.5 years, 5 years
Pathological characteristics of resected material, according to standardized structured report
Time frame: 9-12 months
Cost-effectiveness of both management strategies and comparison
Time frame: 6 months, 1 year, 2.5 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 33846152Hermelijn S, Kersten C, Mullassery D, Muthialu N, Cobanoglu N, Gartner S, Bagolan P, Mesas Burgos C, Sgro A, Heyman S, Till H, Suominen J, Schurink M, Desender L, Losty P, Ertresvag K, Tiddens HAWM, Wijnen RMH, Schnater M; CONNECT study consortium COS development group; CONNECT study consortium COS development group. Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey. BMJ Open. 2021 Apr 12;11(4):e044544. doi: 10.1136/bmjopen-2020-044544.
- Background: PubMed 36010044Kersten CM, Hermelijn SM, Mullassery D, Muthialu N, Cobanoglu N, Gartner S, Bagolan P, Mesas Burgos C, Sgro A, Heyman S, Till H, Suominen J, Schurink M, Desender L, Losty P, Steyaert H, Terheggen-Lagro S, Metzelder M, Bonnard A, Sfeir R, Singh M, Yardley I, Rikkers-Mutsaerts NRVM, van der Ent CK, Qvist N, Cox DW, Peters R, Bannier MAGE, Wessel L, Proesmans M, Stanton M, Hannon E, Zampoli M, Morini F, Tiddens HAWM, Wijnen RMH, Schnater JM. The Management of Asymptomatic Congenital Pulmonary Airway Malformation: Results of a European Delphi Survey. Children (Basel). 2022 Jul 30;9(8):1153. doi: 10.3390/children9081153.
- Derived from this study: PubMed 36931672Kersten CM, Hermelijn SM, Dossche LWJ, Muthialu N, Losty PD, Schurink M, Rietman AB, Poley MJ, van Rosmalen J, Zanen-van den Adel TPL, Ciet P, von der Thusen J, Brosens E, Ijsselstijn H, Tiddens HAWM, Wijnen RMH, Schnater JM. COllaborative Neonatal Network for the first European CPAM Trial (CONNECT): a study protocol for a randomised controlled trial. BMJ Open. 2023 Mar 17;13(3):e071989. doi: 10.1136/bmjopen-2023-071989.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rene MH Wijnen, professor study director
Head of department Pediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective surgical resection of CPAM between 6 and 9 months of age in people with Congenital Pulmonary Airway Malformation, run by Erasmus Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J Marco Schnater, MD, PhD (0031 107036923, j.schnater@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701514, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.