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NCT Number: NCT06664333

Experiences Reported by Siblings of Children Hospitalized in the PICU

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.

Recruiting

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades, Paris, France

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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 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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semi-structured interviews

Other

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.

Primary outcomes

  1. Needs reported by children

    Time frame: 1 month

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène Morel

CONTACT

[email protected]

81653331443

Léo Dr Berger, Doctor

CONTACT

[email protected]

33671287526

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SIBCARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2024
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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