Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT06664333
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experiences Reported by Siblings of Children Hospitalized in the PICU
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Experiences Reported by Siblings of Children Hospitalized in the PICU
Status:
RECRUITING
Status Verified Date:
2025-10
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:
SIBCARE
Brief Summary:
The care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. The needs and feelings of parents are relatively well supported in the literature. However, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience. The study consists of conducting two semi-structured interviews with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second one 1 month after discharge from pediatric intensive care.
Detailed Description:
The care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. The needs and feelings of parents are relatively well supported in the literature. However, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience.
The study consists of conducting two semi-structured interviews, with an estimated duration of 15 to 30 minutes, with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second 1 month after discharge from pediatric intensive care.
The study will concern children and adolescents aged 9 to 18 years old because this is a population at risk in this situation. Concepts of illness, death and its irreversible nature evolve during childhood. By definition, there are three major stages which are: 0-6 years; 7-11 years; 10-18 years. For older children (\> 10 years) these definitions are well established and they would be more at risk of presenting psychiatric disorders later (post-traumatic stress disorder, major depressive syndrome, etc.).
The study consists of conducting two semi-structured interviews, with an estimated duration of 15 to 30 minutes, with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second 1 month after discharge from pediatric intensive care.
The study will concern children and adolescents aged 9 to 18 years old because this is a population at risk in this situation. Concepts of illness, death and its irreversible nature evolve during childhood. By definition, there are three major stages which are: 0-6 years; 7-11 years; 10-18 years. For older children (\> 10 years) these definitions are well established and they would be more at risk of presenting psychiatric disorders later (post-traumatic stress disorder, major depressive syndrome, etc.).
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A01918-39 | OTHER | ID RCB number | View |