Home Parenteral NutritionNPADNCT05048030
Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition
An observational study of Home Parenteral Nutrition, run by Imagine Institute at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 months to 23 years
- Conditions the study is for
- Home Parenteral Nutrition
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 months to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, and their entire family, with gastrointestinal diseases and intestinal failure (IF) requiring long term parenteral nutrition, performed at home (HPN).
Who may be able to join
- Patients followed up by the Necker HPN expert center
- HPN ≥ 12 months
- HPN between 2004 and 2020
- Parents reading and writing French language
Who cannot join
- Refusal of the parents to participate to the survey
Trial locations and contacts
1 site in 1 country.
About this study
Description of the life style of patients and families during the course of long term HPN.
- Evaluation of the familial impact of HPN, and the way it is perceived
- 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
- Analysis of the factors related to specific distress and the protective factors
Read the detailed description
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.
- Conditions
- Home Parenteral Nutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data and socio-familial life style with a child on long-term
socio-familial life style
Measured: Base line
Data involving the management of HPN
Logistics organization
Measured: Base line
Secondary outcomes (3)
Perception of the familial impact of HPN on life style in case of protracted HPN dependency
Child development
Measured: Base line
Satisfaction level of the management by the HPN expert center
Medical and nursing logistics
Measured: Base Line
Factors influencing the familial burden
Type of disease
Measured: Base Line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home Parenteral NutritionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
- Investigators
- Olivier Goulet, MD, PHD, Study director, Department of Pediatric Gastroenterology-Hepatology-Nutrition, National Reference Center for Rare Digestive Diseases, Pediatric Intestinal Failure Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048030
- Sponsor's protocol ID
- HJ-21-NPAD
- Acronym
- NPAD
- Status last verified
- Apr 2025
- First submitted
- 1 Sep 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT05048030
- Acronym / sponsor ID
- NPAD / HJ-21-NPAD
- Conditions
- Home Parenteral Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 17 Sep 2021 (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.
Description of the life style of patients and families during the course of long term HPN.
- Evaluation of the familial impact of HPN, and the way it is perceived
- 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
- Analysis of the factors related to specific distress and the protective factors
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 months to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, and their entire family, with gastrointestinal diseases and intestinal failure (IF) requiring long term parenteral nutrition, performed at home (HPN).
Key inclusion criteria (4 listed)
- Patients followed up by the Necker HPN expert center
- HPN ≥ 12 months
- HPN between 2004 and 2020
- Parents reading and writing French language
Key exclusion criteria (1 listed)
- Refusal of the parents to participate to the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data and socio-familial life style with a child on long-term
Time frame: Base line
socio-familial life style
Data involving the management of HPN
Time frame: Base line
Logistics organization
3 secondary outcomes
Perception of the familial impact of HPN on life style in case of protracted HPN dependency
Time frame: Base line
Satisfaction level of the management by the HPN expert center
Time frame: Base Line
Factors influencing the familial burden
Time frame: Base Line
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Related trials for Home Parenteral Nutrition
Recruiting
Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study
Patients With Home Parenteral Nutrition
Recruiting
Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients
Chronic Intestinal Failure, Intestinal Failure
Recruiting
Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience
Infusions, Intravenous, Administration, Intravenous
Active, not recruitingObservational study
Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments
Home Parenteral Nutrition, Intestinal Failure
RecruitingObservational study
Registry for Patients Receiving Intravenous Nutrition at Home
Parenteral Nutrition, Home
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. This study is not recruiting at the moment.
Olivier Goulet, MD, PHD study director
Department of Pediatric Gastroenterology-Hepatology-Nutrition, National Reference Center for Rare Digestive Diseases, Pediatric Intestinal Failure Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Parenteral Nutrition, run by Imagine Institute at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data and socio-familial life style with a child on long-term (time frame: Base line). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.