Congenital Lung MalformationsMALFPULM2NCT06424392
Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
An observational study of Congenital Lung Malformations, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Congenital Lung Malformations
- What is being tested?
- General Health Questionnaire (GHQ-12), State-Trait Anxiety Inventory (STAI-Y) and Revised Children's Manifest Anxiety Scale (RCMAS)
- How many people
- 434 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to Jun 2027
- Phase
- Observational
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: The families of all children included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age.
Who may be able to join
- Child of the MALFPULM cohort, with their parents
- At least one follow-up visit between 0 and 2 years of age (n= 414 eligible children)
- Non-opposition of the family
Who cannot join
- Child with CLM, but not included in MALFPULM
- Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker Enfants Malades
Paris, 75015
Christophe DELACOURT, MD, PhD, 01 44 49 48 38, christophe.delacourt@aphp.fr
About this study
The absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. The persistent risk of complication, albeit low, is likely to induce over-protective parental behaviours, and to be associated with a sustained family anxiety reaction. The main objective is to test the hypothesis that the absence of surgery has a significant impact on parental anxiety, measurable at 6- 9 years of age.
Read the detailed description
The knowledge of CLMs has been revolutionized by prenatal imaging and the identification of large numbers of CLMs that remain asymptomatic. France is a leader in this field, having set up the only prospective multicentre cohort currently available internationally, with follow-up starting in the prenatal period (MALFPULM). This cohort has already enabled a better description of the prenatal history and the development of an algorithm predictive of the risk of neonatal respiratory distress. The children were followed up to the age of 2 years, and 66% of them were operated on between 0 and 2 years of age. This cohort is a unique opportunity to measure the mid-term impact of this surgical decision, in terms of both medical complications and psychological consequences.
In particular, the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies:
- What is the risk of CLM infection in the absence of surgical removal, and is this risk dependent on the CLM phenotype?
- What is the functional respiratory impact of surgical techniques (thoracoscopy or thoracotomy), depending on the age of the surgery?
- What is the prevalence of musculoskeletal complications according to surgical techniques (thoracoscopy or thoracotomy)?
- What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option?
- What is the psychological impact of the surgical decision on the parents and the child? Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children, and is of great originality because it has never been evaluated. The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease and/or congenital anomalies. For this reason, the investigators chose maternal anxiety as the main criterion of this study. Specifically for CLM, demonstrating the impact of the investigator's decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care, for a better detection of these anxious and/or depressive parental reactions, and a better personalization of the transmission of decisions.
- Conditions
- Congenital Lung Malformations
- Being tested
- General Health Questionnaire (GHQ-12), State-Trait Anxiety Inventory (STAI-Y), Revised Children's Manifest Anxiety Scale (RCMAS), World Health Organization Quality of Life (WHOQOL-BREF), Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"
- Keywords
- Congenital lung malformations, Psychological impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Health Questionnaire (GHQ-12)Other
Anxiety and depression self-reported scales for both parents
State-Trait Anxiety Inventory (STAI-Y)Other
Anxiety and depression self-reported scales for both parents
Revised Children's Manifest Anxiety Scale (RCMAS)Other
Anxiety and depression self-reported scales for children
World Health Organization Quality of Life (WHOQOL-BREF)Other
Quality of life self-reported scales for parents
Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"Other
Parental Educational Competence Self-Evaluation self-reported Questionnaire for parents
Parental interviewOther
The interview will only last about ten minutes and will take place during the first call, if the parents have agreed and are sufficiently available to answer. If the parents are not available, an appointment can be made at a later date
| Study group | Role | What they receive |
|---|---|---|
| 6-9 years children with their parent(s)with fetal diagnoses of CLM | 6-9 years children with their parent(s) with fetal diagnoses of CLM and included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age. Receives: Other: General Health Questionnaire (GHQ-12); Other: State-Trait Anxiety Inventory (STAI-Y); Other: Revised Children's Manifest Anxiety Scale (RCMAS); Other: World Health Organization Quality of Life (WHOQOL-BREF); Other: Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"; Other: Parental interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal anxiety level
The level of maternal anxiety is measured using the GHQ-12 anxiety scale. The GHQ ( General Health Questionnaire) consists of 12 items, each assessing the severity of a mental problem over the past few weeks. Each reponse is scored from 0 to 3, with a total score ranging from 0 to 36. Higher scores indicate poorer health.
Measured: 1 year
Secondary outcomes (13)
Impact of the surgical decision on respiratory morbidity - lower respiratory tract infections
Number of lower respiratory tract infections, either documented (radiological opacity) or not, in the last 12 months and from birth to the date of evaluation
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - hospitalizations
Number of hospitalizations for respiratory reasons in the last 12 months and from birth to the date of evaluation
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - severe wheezing respiratory exacerbations
Number of severe wheezing respiratory exacerbations in the last 12 months, defined as requiring oral corticosteroids, emergency visit and/or hospitalization
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - treatment
Current regular treatment for respiratory purposes, defined as daily treatment for at least 3 consecutive months in the last 12 months
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - lung function tests
Following parameters will be collected: date of performance, weight and height at date of performance, total lung capacity (TLC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), Forced expiratory flow at 25-75% (FEF25-75%), transfer factor of the lung for carbon monoxide (TLCO). FVC, FEV1, and FEF25-75%. These measurements will allow to identify following functional profiles:
- lung function restriction, defined by TLC lower than -1.645 Z score
- airway obstruction, defined by FEV1/FVC lower than -1.645 Z score, and its reversibility, defined by an improvement of at least 12% of the FV1 after inhalation of salbutamol.
- impaired diffusion capacity, defined by DLCO lower than -1.645 Z score.
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - thoracic deformities
The parents's declare rate of thoracic deformities
Measured: 1 year
Impact of the surgical decision on respiratory morbidity - burden of the medical or surgical follow-up
The burden of the medical or surgical follow-up will be evaluated by the number of specialist consultations and the number of CT or MRI scans
Measured: 1 year
Anxiety and depression - GHQ-12
The 12-item GHQ (General Health Questionnaire) was designed to be a self-administered screening test aimed at detecting minor psychiatric disorders and had been and validated in different languages, including French. It allows to estimate the prevalence of psychological distress in a given population (34). The GHQ-12 consists of 12 items, each one assessing the severity of a mental problem over the past few weeks, with four response options, and using six positively phrased and six negatively phrased. It takes less than 5 minutes to complete. It is scored from 0 to 3 for each response with a total possible score on the ranging from 0 to 36. High scores indicate worse health.
Measured: 1 year
Anxiety and depression - STAI-Y
The State-Trait Anxiety Inventory (STAI-Y) is a 20-item self-measure of state anxiety level in parents, complementary of GHQ-28. It reflects the current subjective feeling of tension, apprehension, nervousness, and worry and is widely used both in practice and in clinical research.
Measured: 1 year
Anxiety and depression - RCMAS
The RCMAS is a 37-item, self-report instrument designed to assess the level and nature of anxiety. A Total Anxiety score is computed based on 28 items, which are divided into three anxiety subscales: physiological anxiety (10 items about somatic manifestations of anxiety such as sleep difficulties, nausea and fatigue), worry/oversensitivity (11 items measuring obsessive concerns about a variety of things, most of which are typically vague and ill-defined, as well as fears about being hurt or emotionally isolated), and social concerns/concentration (7 items measuring distracting thoughts and fears that have a social or interpersonal nature). The remaining nine items on the RCMAS constitute the Lie subscale. A high score indicates a high level of anxiety or lie on that subscale.
Measured: 1 year
Quality of life - WHOQOL-BREF
The WHOQOL-BREF is an abbreviated form of the WHOQOL-100 with only 26 items. It is an instrument for recording subjective quality of life. This is defined as an individual perception of one's own life situation in the context of culture and value system as well as personal goals, expectations, evaluation criteria and interests. It is a self-questionnaire that includes the four domains "physical health", "psychological well-being", "social relationships" and "environment". The items are answered using a five-level scale. The scales have a very high internal consistency. It is validated in several languages, including French.
Measured: 1 year
Parenting Sense of Competence questionnaire
This questionnaire evaluates the parent's sense of competence in his or her role as an educator and has two components: the "skill/knowledge" factor, which evaluates the respondents' perception of the skills and knowledge they have acquired in order to be adequate parents (8 items); the "value/ease" factor, which evaluates the value that the respondent places on the role of parent, as well as his or her ease in this role (9 items).
Measured: 1 year
Over-protective parental behaviours
The over-protective parental behaviours is defined by the age of attendance in first community (5 or more children), the care arrangements between 0 and 2 years, the after-school activities in the previous year and the travel outside France in the last two years
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start19 Dec 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Lung MalformationsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe DELACOURT, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424392
- Sponsor's protocol ID
- 2024-A00576-41
- Acronym
- MALFPULM2
- Status last verified
- Mar 2026
- First submitted
- 16 May 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
- ClinicalTrials.gov ID
- NCT06424392
- Acronym / sponsor ID
- MALFPULM2 / 2024-A00576-41
- Conditions
- Congenital Lung Malformations
- Keywords
- Congenital lung malformations, Psychological impact
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 May 2024 (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 absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. The persistent risk of complication, albeit low, is likely to induce over-protective parental behaviours, and to be associated with a sustained family anxiety reaction. The main objective is to test the hypothesis that the absence of surgery has a significant impact on parental anxiety, measurable at 6- 9 years of age.
Detailed description
The knowledge of CLMs has been revolutionized by prenatal imaging and the identification of large numbers of CLMs that remain asymptomatic. France is a leader in this field, having set up the only prospective multicentre cohort currently available internationally, with follow-up starting in the prenatal period (MALFPULM). This cohort has already enabled a better description of the prenatal history and the development of an algorithm predictive of the risk of neonatal respiratory distress. The children were followed up to the age of 2 years, and 66% of them were operated on between 0 and 2 years of age. This cohort is a unique opportunity to measure the mid-term impact of this surgical decision, in terms of both medical complications and psychological consequences.
In particular, the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies:
- What is the risk of CLM infection in the absence of surgical removal, and is this risk dependent on the CLM phenotype?
- What is the functional respiratory impact of surgical techniques (thoracoscopy or thoracotomy), depending on the age of the surgery?
- What is the prevalence of musculoskeletal complications according to surgical techniques (thoracoscopy or thoracotomy)?
- What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option?
- What is the psychological impact of the surgical decision on the parents and the child? Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children, and is of great originality because it has never been evaluated. The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease and/or congenital anomalies. For this reason, the investigators chose maternal anxiety as the main criterion of this study. Specifically for CLM, demonstrating the impact of the investigator's decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care, for a better detection of these anxious and/or depressive parental reactions, and a better personalization of the transmission of decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6-9 years children with their parent(s)with fetal diagnoses of CLM | – | Other: General Health Questionnaire (GHQ-12), Other: State-Trait Anxiety Inventory (STAI-Y), Other: Revised Children's Manifest Anxiety Scale (RCMAS), Other: World Health Organization Quality of Life (WHOQOL-BREF), Other: Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)", Other: Parental interview6-9 years children with their parent(s) with fetal diagnoses of CLM and included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The families of all children included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age.
Key inclusion criteria (3 listed)
- Child of the MALFPULM cohort, with their parents
- At least one follow-up visit between 0 and 2 years of age (n= 414 eligible children)
- Non-opposition of the family
Key exclusion criteria (2 listed)
- Child with CLM, but not included in MALFPULM
- Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.
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 |
|---|---|---|
| General Health Questionnaire (GHQ-12)Anxiety and depression self-reported scales for both parents | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
| State-Trait Anxiety Inventory (STAI-Y)Anxiety and depression self-reported scales for both parents | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
| Revised Children's Manifest Anxiety Scale (RCMAS)Anxiety and depression self-reported scales for children | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
| World Health Organization Quality of Life (WHOQOL-BREF)Quality of life self-reported scales for parents | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
| Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"Parental Educational Competence Self-Evaluation self-reported Questionnaire for parents | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
| Parental interviewThe interview will only last about ten minutes and will take place during the first call, if the parents have agreed and are sufficiently available to answer. If the parents are not available, an appointment can be made at a later date | Other | 6-9 years children with their parent(s)with fetal diagnoses of CLM |
Primary outcome
maternal anxiety level
Time frame: 1 year
The level of maternal anxiety is measured using the GHQ-12 anxiety scale. The GHQ ( General Health Questionnaire) consists of 12 items, each assessing the severity of a mental problem over the past few weeks. Each reponse is scored from 0 to 3, with a total score ranging from 0 to 36. Higher scores indicate poorer health.
13 secondary outcomes
Impact of the surgical decision on respiratory morbidity - lower respiratory tract infections
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - hospitalizations
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - severe wheezing respiratory exacerbations
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - treatment
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - lung function tests
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - thoracic deformities
Time frame: 1 year
Impact of the surgical decision on respiratory morbidity - burden of the medical or surgical follow-up
Time frame: 1 year
Anxiety and depression - GHQ-12
Time frame: 1 year
Anxiety and depression - STAI-Y
Time frame: 1 year
Anxiety and depression - RCMAS
Time frame: 1 year
Quality of life - WHOQOL-BREF
Time frame: 1 year
Parenting Sense of Competence questionnaire
Time frame: 1 year
Over-protective parental behaviours
Time frame: 1 year
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Christophe DELACOURT principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Lung Malformations, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Christophe DELACOURT, MD, PhD (+33 144494838, christophe.delacourt@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal anxiety level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.