NCT06424392 Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
| NCT ID | NCT06424392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Congenital Lung Malformations |
| Study Type | OBSERVATIONAL |
| Enrollment | 434 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 434 participants in total. It began in 2024-12-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Christophe DELACOURT
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06424392 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 9 Years, studying Congenital Lung Malformations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06424392 currently recruiting?
Yes, NCT06424392 is actively recruiting participants. Contact the research team at christophe.delacourt@aphp.fr for enrollment information.
Where is the NCT06424392 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06424392 clinical trial?
NCT06424392 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Christophe DELACOURT at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 434 participants.