Intensive Care PediatricSIBCARENCT06664333
Experiences Reported by Siblings of Children Hospitalized in the PICU
An observational study of Intensive Care Pediatric, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Intensive Care Pediatric
- What is being tested?
- Semi-structured interviews
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jan 2025to 21 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Death of patients
- Language barrier (French not mastered)
- Inability to participate in a semi-structured interview (intellectual disability)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Léo MD Berger, Doctor, 33671287526, leo.berger@aphp.fr
- Recruiting
Hôpital Robert Debré
Paris, 75019
Stéphane MD, PhD Dauger, Doctor, stephane.dauger@aphp.fr
About this study
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.
Read the 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.).
- Conditions
- Intensive Care Pediatric
- Being tested
- Semi-structured interviews
- Keywords
- Pediatric intensive care hospitalisation, Siblings, Semi-structured interviews, Post-traumatic stress disorder, Major depressive syndrome
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs reported by children
Qualitative interpretation of the responses given by children during the two interviews.
Measured: 1 month
Secondary outcomes (3)
Assessment of the impact on the daily life of siblings following their visit to the intensive care unit
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.
Measured: 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
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.
Measured: 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
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start21 Jan 2025
- Primary completion21 Dec 2027 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intensive Care PediatricStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Léo MD Berger, Doctor, Principal investigator, Assistance Publique - Hôpitaux de ParisAgathe MD Béranger, Doctor, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664333
- Sponsor's protocol ID
- APHP241201
- Other IDs
- 2024-A01918-39
- Acronym
- SIBCARE
- Status last verified
- Oct 2025
- First submitted
- 28 Oct 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32640860Brooten 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.
PubMed 30766016Lovgren 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.
PubMed 26260031Abela 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.
PubMed 31874458Abela 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.
PubMed 35287059Gonzalez-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.
PubMed 34745701Davidson 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.
PubMed 27984278McPeake 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.
PubMed 37698596Kentish-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.
PubMed 34152418
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences Reported by Siblings of Children Hospitalized in the PICU
- ClinicalTrials.gov ID
- NCT06664333
- Acronym / sponsor ID
- SIBCARE / APHP241201
- Conditions
- Intensive Care Pediatric
- Keywords
- Pediatric intensive care hospitalisation, Siblings, Semi-structured interviews, Post-traumatic stress disorder, Major depressive syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Dec 2027 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siblings of pediatric intensive care hospitalized children | – | Other: Semi-structured interviewsSiblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital, aged of 9 to 18 years old. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Death of patients
- Language barrier (French not mastered)
- Inability to participate in a semi-structured interview (intellectual disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsThe 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. | Other | Siblings of pediatric intensive care hospitalized children |
Primary outcome
Needs reported by children
Time frame: 1 month
Qualitative interpretation of the responses given by children during the two interviews.
3 secondary outcomes
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 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 medium-term impact on the daily life of siblings after the discharge of their brother or sister from intensive care
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Background: PubMed 32640860Youngblut 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.
- Background: PubMed 30766016Brooten 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.
- Background: PubMed 26260031Lovgren 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.
- Background: PubMed 31874458Abela 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.
- Background: PubMed 35287059Abela 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.
- Background: PubMed 34745701Gonzalez-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.
- Background: PubMed 27984278Davidson 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.
- Background: PubMed 37698596McPeake 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.
- Background: PubMed 34152418Kentish-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.
- Ricignuolo C, Fostini O. Quelle place pour les frères et sœurs ?: Histoire de la première rencontre entre la fratrie et le nouveau-né hospitalisé. Carnet PSY \[Internet\]. 1 nov 2013 \[cité 2 juill 2024\];N° 175(8):35-7Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Léo MD Berger, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
Agathe MD Béranger, Doctor study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Pediatric, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léo Dr Berger, Doctor (33671287526, leo.berger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs reported by children (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664333, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.