Impact of elective surgery on children with congenital lung malformations and their parents
Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Assistance Publique - Hôpitaux de Paris · NCT06424392
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 |
|---|---|
| Enrollment | 434 (estimated) |
| Ages | 6 Years to 9 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06424392 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Lung Malformations, Congenital lung malformations, Psychological impact