NCT06424392

Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 434 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Lung Malformations

Interventions

Type	Name	Description
OTHER	General Health Questionnaire (GHQ-12)	Anxiety and depression self-reported scales for both parents
OTHER	State-Trait Anxiety Inventory (STAI-Y)	Anxiety and depression self-reported scales for both parents
OTHER	Revised Children's Manifest Anxiety Scale (RCMAS)	Anxiety and depression self-reported scales for children
OTHER	World Health Organization Quality of Life (WHOQOL-BREF)	Quality of life self-reported scales for parents
OTHER	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	Parental interview	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

Timeline

• Start date: 2024-12-19
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-05-22
• Last updated: 2026-03-23

Locations

1 site across 1 country: France