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

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.

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Key information

Conditions

Congenital Malformation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Atresia Esophageal Diseases Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jeanne de Flandres, CHU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

interview

Other

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 outcomes

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.

Time frame: at 1 year

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

University of Lille Nord de France

Registry information

Official study 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

Acronym: INEMAT

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jun 21, 2018
Registry last updated: Oct 2, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed