Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

NCT06424392 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2024-12-19

Last updated

2026-03-23

Condition(s) studied

Congenital Lung Malformations

Investigational drug(s) / intervention(s)

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)"Parental interview

General Health Questionnaire (GHQ-12): Anxiety and depression self-reported scales for both parents

State-Trait Anxiety Inventory (STAI-Y): Anxiety and depression self-reported scales for both parents

Revised Children's Manifest Anxiety Scale (RCMAS): Anxiety and depression self-reported scales for children

World Health Organization Quality of Life (WHOQOL-BREF): Quality of life self-reported scales for parents

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

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

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

9 Years

Healthy volunteers

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 outcome measure(s)

maternal anxiety level — 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.

Trial sites (1)

Facility	City	Region	Status
Hôpital Necker Enfants Malades	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06424392 on ClinicalTrials.gov ↗ ← All trials in France