Back to resultsThe Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation (INEMAT)
Primary Purpose
Congenital Malformation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interview
Sponsored by
About this trial
This is an interventional other trial for Congenital Malformation focused on measuring Oesophageal Atresia, Congenital Diaphragmatic Hernia, Short Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- to be the parent of a child aged 12 to 36 months old having undergone neonatal surgery following oesophageal Atresia, congenital diaphragmatic hernia or short bowel syndrome diagnosis.
- to have lived with the child during his first year of life
- to have social security coverage
- to speak french
Exclusion Criteria:
- to be a person not having the capacity to consent or enjoying social protection (tutorship or guardianship);
- to be a person deprived of liberty;
- to be a minor;
- to be pregnant.
Sites / Locations
- Hôpital Jeanne de Flandres, CHU
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
interview
Arm Description
There are two data collection phases (individual interviews +/- focus groups) with parents of children with esophageal atresia, congenital diaphragmatic hernia or short bowel syndrome.
Outcomes
Primary Outcome Measures
Level of the dynamics parental adjustment for the period from the announcement of the diagnosis to one year of the child with a rare abdominothoracic malformation requiring neonatal surgery.
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease, describing the socio-demographic characteristics of parents and children with malformation
Secondary Outcome Measures
Full Information
NCT ID
NCT03565822
First Posted
April 24, 2018
Last Updated
October 1, 2019
Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France
1. Study Identification
Unique Protocol Identification Number
NCT03565822
Brief Title
The Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation
Acronym
INEMAT
Official Title
Qualitative Study of the Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation on the Parental Adjustment of the First Year
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
University of Lille Nord de France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Malformation
Keywords
Oesophageal Atresia, Congenital Diaphragmatic Hernia, Short Bowel Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interview
Arm Type
Other
Arm Description
There are two data collection phases (individual interviews +/- focus groups) with parents of children with esophageal atresia, congenital diaphragmatic hernia or short bowel syndrome.
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
individual interview and/or focus group Grounded theory qualitative analysis of data related to socio-demographic and child characteristics data First, data will be prepared for qualitative analysis. Digital audio files from the focus groups will be transcribed verbatim and questionnaire data will be entered into an Excel/word data file. Second, focus group data will be qualitatively analyzed using the constant comparative process. A qualitative data analysis program, NVivo11 (Victoria, Australia/ QSR International)) will be used to assist with this coding process.
Primary Outcome Measure Information:
Title
Level of the dynamics parental adjustment for the period from the announcement of the diagnosis to one year of the child with a rare abdominothoracic malformation requiring neonatal surgery.
Description
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease, describing the socio-demographic characteristics of parents and children with malformation
Time Frame
at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
to be the parent of a child aged 12 to 36 months old having undergone neonatal surgery following oesophageal Atresia, congenital diaphragmatic hernia or short bowel syndrome diagnosis.
to have lived with the child during his first year of life
to have social security coverage
to speak french
Exclusion Criteria:
to be a person not having the capacity to consent or enjoying social protection (tutorship or guardianship);
to be a person deprived of liberty;
to be a minor;
to be pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Michaud, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jeanne de Flandres, CHU
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation
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