Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations

Recruiting now

Conditions studied: Congenital Lung Malformations

In brief

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.

Key facts

Study ID

NCT06424392

Run by

Assistance Publique - Hôpitaux de Paris

People needed

434

Starts

2024-12-19

Expected to finish

2027-06-01

Last updated by the study team

2026-03-23

Who can join

Age: 6 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Child with CLM, but not included in MALFPULM
• Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.

Where it is running

• Hôpital Necker Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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