Impact of elective surgery on children with congenital lung malformations and their parents
Official title: Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Run by Assistance Publique - Hôpitaux de Paris · NCT06424392 · Data updated 2026-11-12
This study looks at how elective surgery affects children with congenital lung malformations and their parents, focusing on their breathing and emotional well-being.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 9 Years |
| Sex | All |
| Enrollment | 434 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT06424392 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children from the MALFPULM cohort who have undergone at least one follow-up visit between 0 and 2 years of age, along with their parents.
✕Probably not a fit
Patients who are not part of the MALFPULM cohort or whose parents experienced prenatal or neonatal death may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the respiratory and psychological effects of elective surgery on children with congenital lung malformations (CLMs) and their parents. It utilizes a unique multicenter cohort that began following children from the prenatal period, allowing for an in-depth analysis of the implications of surgical decisions. The study aims to measure parental anxiety and the medical outcomes associated with surgical versus non-surgical approaches to managing CLMs. Various psychological assessments will be conducted to evaluate the impact on both the child and the family over time.
Why it matters
Potential benefit: If successful, this study could provide insights into the psychological and medical outcomes of surgical decisions for children with congenital lung malformations, potentially guiding future treatment approaches.
How similar studies have gone: While this study builds on existing knowledge from the MALFPULM cohort, it addresses specific psychological impacts that have not been extensively studied, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hôpital Necker Enfants Malades
Paris, France Recruiting
Study contacts
- Principal investigator: Christophe DELACOURT — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Christophe DELACOURT, MD, PhD
- Email: christophe.delacourt@aphp.fr
- Phone: +33 144494838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.