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Completed

NCT Number: NCT05048030

Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition

Description of the life style of patients and families during the course of long term HPN.

1. Evaluation of the familial impact of HPN, and the way it is perceived 2. Evaluation of the satisfaction regarding the management by the multi-professional team (Medical, nursing, home care company and logistic, social, psychologist etc..) for improving the global management of these challenging patients 3. Analysis of the factors related to specific distress and the protective factors

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Key information

Conditions

Home Parenteral Nutrition

Age range

18 month–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Necker - Enfants malades

Paris, France

About this study

Gastrointestinal diseases may cause intestinal failure (IF) requiring long term parenteral nutrition (PN) which is, most of the time, performed at home (HPN).

However such conditions represent a great burden for the parents and the family.

The birth of a child with such disease changes the life of the entire family including life style, leisures, social relationships and professional activities.

These condition obligate to change the personal and familial organization according to the course of the disease. The PN treatment which was seen as life saving when first started might become a burden altogether physically and psychologically for the child and his/her family.

The Necker-Enfants Malades hospital developed home PN in the early eighties as an alternative to very long hospitalizations.

Nowadays, there are 7 expert centers for HPN in France. The Necker HPN program is the oldest and the largest looking after i a third of the 400 children on HPN in France.

Our organization is based on a specializednursing team together with medical doctors specialized in pediatric clinical nutrition.

The nursing team is also a teaching team for training the parents for daily PN care. The HPN team works in collaboration with professional partners: pharmacists, dieticians, psychologists, occupational therapistsand speech specialists as well as with social workers.

Results of our clinical activities have been published in international peer review journals. However those publications reported only clinical data in terms of diagnosis, prognosis, mortality, morbidity and growth.There was any data on family quality of life (QOL) and on life style changes (LSC). In other words, by reporting only on medical aspects, there was any analyze on familial, psychosocial and professional impact of long term HPN.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients followed up by the Necker HPN expert center
  • HPN ≥ 12 months
  • HPN between 2004 and 2020
  • Parents reading and writing French language

Exclusion criteria

  • Refusal of the parents to participate to the survey

Treatment and study plan

Primary outcomes

  1. Demographic data and socio-familial life style with a child on long-term

    Time frame: Base line

    socio-familial life style

  2. Data involving the management of HPN

    Time frame: Base line

    Logistics organization

Secondary outcomes

  1. Perception of the familial impact of HPN on life style in case of protracted HPN dependency

    Time frame: Base line

    Child development

  2. Satisfaction level of the management by the HPN expert center

    Time frame: Base Line

    Medical and nursing logistics

  3. Factors influencing the familial burden

    Time frame: Base Line

    Type of disease

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Collaborators

  • Hôpital Necker-Enfants Malades

Registry information

Acronym: NPAD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Apr 30, 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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