Clinical trial NCT06664333: Experiences Reported by Siblings of Children Hospitalized in the PICU
Official title: Experiences Reported by Siblings of Children Hospitalized in the PICU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Pediatric
Keywords: Pediatric intensive care hospitalisation
Siblings
Semi-structured interviews
Post-traumatic stress disorder
Major depressive syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents aged 10 to 18 years whose sister or brother is hospitalized in pediatric intensive care at Necker-Enfants Malades hospital or Robert Debré hospital.

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 10 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.).

Eligibility criteria: Inclusion Criteria:

* Children and adolescents aged 10 to 18 years
* Whose sister or brother is hospitalized in pediatric intensive care at Necker-Enfants Malades hospital or Robert Debré hospital
* Holders of parental authority and children or adolescents informed and consenting to participate in the study

Exclusion Criteria:

* Death of patients
* Language barrier (French not mastered)
* Inability to participate in a semi-structured interview (intellectual disability)

Primary outcomes:
measure: Needs reported by children
timeFrame: 1 month
Secondary outcomes:
measure: Assessment of the impact on the daily life of siblings following their visit to the intensive care unit
timeFrame: 1 month
measure: Assessment of the feelings during the visit of children and adolescents following the hospitalization of their brother or sister in pediatric intensive care
timeFrame: 1 month
measure: Assessment of the medium-term impact on the daily life of siblings after the discharge of their brother or sister from intensive care
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Léo MD Berger, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Agathe MD Béranger, Doctor
role: STUDY_DIRECTOR
References:
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citation: Gonzalez-Dambrauskas S, Mislej C, Vasquez-Hoyos P, Rotta AT. Family Presence and Visitation Practices in Latin American PICUs: An International Survey. J Pediatr Intensive Care. 2020 Sep 14;10(4):276-281. doi: 10.1055/s-0040-1716831. eCollection 2021 Nov.
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