NCT06664333

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2027

Last Updated

December 1, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

October 28, 2024

Last Update Submit

November 24, 2025

Conditions

Keywords

Pediatric intensive care hospitalisationSiblingsSemi-structured interviewsPost-traumatic stress disorderMajor depressive syndrome

Outcome Measures

Primary Outcomes (1)

  • Needs reported by children

    Qualitative interpretation of the responses given by children during the two interviews.

    1 month

Secondary Outcomes (3)

  • Assessment of the impact on the daily life of siblings following their visit to the intensive care unit

    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

    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

    1 month

Study Arms (1)

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.

Other: Semi-structured interviews

Interventions

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.

Siblings of pediatric intensive care hospitalized children

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

Hôpital Robert Debré

Paris, 75019, France

RECRUITING

Related Publications (9)

  • 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.

    PMID: 32640860BACKGROUND
  • 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.

    PMID: 30766016BACKGROUND
  • 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.

    PMID: 26260031BACKGROUND
  • 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.

    PMID: 31874458BACKGROUND
  • 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.

    PMID: 35287059BACKGROUND
  • 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.

    PMID: 34745701BACKGROUND
  • 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.

    PMID: 27984278BACKGROUND
  • 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.

    PMID: 37698596BACKGROUND
  • 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.

    PMID: 34152418BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Léo MD Berger, Doctor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Agathe MD Béranger, Doctor

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Léo Dr Berger, Doctor

CONTACT

Hélène Morel

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

January 21, 2025

Primary Completion (Estimated)

December 21, 2027

Study Completion (Estimated)

December 21, 2027

Last Updated

December 1, 2025

Record last verified: 2025-10

Locations