The Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation

Congenital Malformation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565822
• Other study ID #: 2015_93
• Secondary ID: 2016-A02050-51
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Malformation

Intervention

Other:
• Interview
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.

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 1 year