NCT04014543

Brief Summary

The goal of this reasearch project is to study the quality of life of caregivers and children with generic questionnaires, validated and used in other pathologies and chronic diseases of the child. This will allow reproducibility and comparisons to other populations, general or other chronic diseases (acute leukemias ...) This is to conduct a pilot study, preliminary to the construction of a larger study, longitudinal with several evaluation times.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

June 18, 2019

Last Update Submit

July 9, 2019

Conditions

Gastrostomy

Outcome Measures

Primary Outcomes (1)

  • Comparison of the body mass index

    Observation of a decrease in body mass index after gastrostomy

    19 moths

Study Arms (1)

Gastrostomy

EXPERIMENTAL

Gastrostomy involves creating an opening between the skin and the stomach. It allows the administration of nutrition solutes or food directly into the stomach without passing through the mouth and esophagus. It is a method widely used since the 1980s for enteral nutrition. In the field of pediatrics, gastrostomy is considered in chronic diseases when enteral nutrition is necessary in the long term.

Other: gastronomy

Interventions

gastronomyOTHER

to study the quality of life of caregivers and children with generic questionnaires (13-16), validated and used in other pathologies and chronic diseases of the child. This will allow reproducibility and comparisons to other populations, general or other chronic diseases (acute leukemias ...) This is to conduct a pilot study, preliminary to the construction of a larger study, longitudinal with several evaluation times.

Also known as: investigation
Gastrostomy

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child:
  • month to 17 years old;
  • Accepting to participate in the study;
  • Having a pathology requiring enteral nutrition in the long term exclusive or mixed;
  • Having the programming of the insertion of percutaneous gastrostomy in the multidisciplinary pediatric ward.
  • Helping :
  • Accepting to participate in the study;
  • Having the ability to comply with the protocol requirements (in particular: understanding and speaking French).
  • Siblings:
  • to 17 years old;
  • Accepting to participate in the study;
  • Having the ability to comply with the requirements of the protocol (understanding and speaking French, presenting no sensory, motor, cognitive or severe chronic illness);
  • Living in the same home as the sick child.

You may not qualify if:

  • Child:
  • Refusing to participate in the study;
  • Surgical, radiological or emergency gastrostomy.
  • Helping :
  • Inability to comply with study protocol, or investigator uncertainty about willingness or ability to comply with protocol requirements;
  • Refusing to participate in the study.
  • Siblings:
  • Refusing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Interventions

Contact Tracing

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesPublic HealthEnvironment and Public HealthCommunicable Disease ControlPublic Health Practice

Central Study Contacts

Alexandre Fabre

CONTACT

04 91 38 60 40alexander.fabre@ap-hm.fr

Claire MORANDO

CONTACT

0491382747promotion.interne@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: caregivers and children
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 10, 2019

Study Start

January 1, 2019

Primary Completion

July 31, 2020

Study Completion

October 30, 2020

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

FR(1)