Clinical trial NCT06424392: Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Official title: Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Lung Malformations
Keywords: Congenital lung malformations
Psychological impact
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 434
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Child with CLM, but not included in MALFPULM
* Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.

Primary outcomes:
measure: maternal anxiety level
timeFrame: 1 year
Secondary outcomes:
measure: Impact of the surgical decision on respiratory morbidity - lower respiratory tract infections
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - hospitalizations
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - severe wheezing respiratory exacerbations
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - treatment
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - lung function tests
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - thoracic deformities
timeFrame: 1 year
measure: Impact of the surgical decision on respiratory morbidity - burden of the medical or surgical follow-up
timeFrame: 1 year
measure: Anxiety and depression - GHQ-12
timeFrame: 1 year
measure: Anxiety and depression - STAI-Y
timeFrame: 1 year
measure: Anxiety and depression - RCMAS
timeFrame: 1 year
measure: Quality of life - WHOQOL-BREF
timeFrame: 1 year
measure: Parenting Sense of Competence questionnaire
timeFrame: 1 year
measure: Over-protective parental behaviours
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christophe DELACOURT
role: PRINCIPAL_INVESTIGATOR
References: