- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664333
Experiences Reported by Siblings of Children Hospitalized in the PICU (SIBCARE)
Study Overview
Status
Conditions
Intervention / Treatment
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.).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Léo Dr Berger, Doctor
- Phone Number: 33671287526
- Email: leo.berger@aphp.fr
Study Contact Backup
- Name: Hélène Morel
- Phone Number: 81653331443
- Email: helene.morel@aphp.fr
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- Hôpital Necker-Enfants Malades
-
Contact:
- Léo MD Berger, Doctor
- Phone Number: 33671287526
- Email: leo.berger@aphp.fr
-
Paris, France, 75019
- Recruiting
- Hopital Robert Debre
-
Contact:
- Stéphane MD, PhD Dauger, Doctor
- Email: stephane.dauger@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children and adolescents aged 9 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Siblings of pediatric intensive care hospitalized children
Siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital, aged of 9 to 18 years old.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Needs reported by children
Time Frame: 1 month
|
Qualitative interpretation of the responses given by children during the two interviews.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of the impact on the daily life of siblings following their visit to the intensive care unit
Time Frame: 1 month
|
Assessment of the impact on the daily life of siblings following their visit to the intensive care unit to see their brother/sister. Qualitative interpretation of the responses given by children during the two interviews. |
1 month
|
|
Assessment of the feelings during the visit of children and adolescents following the hospitalization of their brother or sister in pediatric intensive care
Time Frame: 1 month
|
Assessment of the feelings during the visit of children and adolescents following the hospitalization of their brother or sister in pediatric intensive care. Qualitative interpretation of the responses given by children during the two interviews. |
1 month
|
|
Assessment of the medium-term impact on the daily life of siblings after the discharge of their brother or sister from intensive care
Time Frame: 1 month
|
Assessment of the medium-term impact on the daily life of siblings after the discharge of their brother or sister from intensive care. Qualitative interpretation of the responses given by children during the two interviews. |
1 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Léo MD Berger, Doctor, Assistance Publique - Hôpitaux de Paris
- Study Director: Agathe MD Béranger, Doctor, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Youngblut JM, Brooten D. What Children Wished They Had/Had Not Done and Their Coping in the First Thirteen Months after Their Sibling's Neonatal/Pediatric Intensive Care Unit/Emergency Department Death. J Palliat Med. 2021 Feb;24(2):226-232. doi: 10.1089/jpm.2019.0538. Epub 2020 Jul 8.
- Brooten DA, Youngblut JM, Roche RM, Caicedo CL, Page TF. Surviving Siblings' Illnesses, Treatments/Health Services over 13 Months after a Sibling's Death. J Child Fam Stud. 2018 Jun;27(6):2049-2056. doi: 10.1007/s10826-018-1044-1. Epub 2018 Mar 19.
- Lovgren M, Jalmsell L, Eilegard Wallin A, Steineck G, Kreicbergs U. Siblings' experiences of their brother's or sister's cancer death: a nationwide follow-up 2-9 years later. Psychooncology. 2016 Apr;25(4):435-40. doi: 10.1002/pon.3941. Epub 2015 Aug 11.
- Abela KM, Wardell D, Rozmus C, LoBiondo-Wood G. Impact of Pediatric Critical Illness and Injury on Families: An Updated Systematic Review. J Pediatr Nurs. 2020 Mar-Apr;51:21-31. doi: 10.1016/j.pedn.2019.10.013. Epub 2019 Dec 23.
- Abela KM, Casarez RL, Kaplow J, LoBiondo-Wood G. Siblings' experience during pediatric intensive care hospitalization. J Pediatr Nurs. 2022 May-Jun;64:111-118. doi: 10.1016/j.pedn.2022.02.008. Epub 2022 Mar 11.
- 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.
- McPeake J, Castro P, Kentish-Barnes N, Cuzco C, Azoulay E, MacTavish P, Quasim T, Puxty K. Post-hospital recovery trajectories of family members of critically ill COVID-19 survivors: an international qualitative investigation. Intensive Care Med. 2023 Oct;49(10):1203-1211. doi: 10.1007/s00134-023-07202-9. Epub 2023 Sep 12.
- Kentish-Barnes N, Cohen-Solal Z, Morin L, Souppart V, Pochard F, Azoulay E. Lived Experiences of Family Members of Patients With Severe COVID-19 Who Died in Intensive Care Units in France. JAMA Netw Open. 2021 Jun 1;4(6):e2113355. doi: 10.1001/jamanetworkopen.2021.13355.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP241201
- 2024-A01918-39 (Other Identifier: ID RCB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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