Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MALFPULM2
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
Detailed Description:
The knowledge of CLMs has been revolutionized by prenatal imaging and the identification of large numbers of CLMs that remain asymptomatic France is a leader in this field having set up the only prospective multicentre cohort currently available internationally with follow-up starting in the prenatal period MALFPULM This cohort has already enabled a better description of the prenatal history and the development of an algorithm predictive of the risk of neonatal respiratory distress The children were followed up to the age of 2 years and 66 of them were operated on between 0 and 2 years of age This cohort is a unique opportunity to measure the mid-term impact of this surgical decision in terms of both medical complications and psychological consequences
In particular the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies
What is the risk of CLM infection in the absence of surgical removal and is this risk dependent on the CLM phenotype
What is the functional respiratory impact of surgical techniques thoracoscopy or thoracotomy depending on the age of the surgery
What is the prevalence of musculoskeletal complications according to surgical techniques thoracoscopy or thoracotomy
What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option
What is the psychological impact of the surgical decision on the parents and the child Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children and is of great originality because it has never been evaluated The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease andor congenital anomalies For this reason the investigators chose maternal anxiety as the main criterion of this study Specifically for CLM demonstrating the impact of the investigators decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care for a better detection of these anxious andor depressive parental reactions and a better personalization of the transmission of decisions
In particular the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies
What is the risk of CLM infection in the absence of surgical removal and is this risk dependent on the CLM phenotype
What is the functional respiratory impact of surgical techniques thoracoscopy or thoracotomy depending on the age of the surgery
What is the prevalence of musculoskeletal complications according to surgical techniques thoracoscopy or thoracotomy
What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option
What is the psychological impact of the surgical decision on the parents and the child Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children and is of great originality because it has never been evaluated The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease andor congenital anomalies For this reason the investigators chose maternal anxiety as the main criterion of this study Specifically for CLM demonstrating the impact of the investigators decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care for a better detection of these anxious andor depressive parental reactions and a better personalization of the transmission of decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None