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

NCT03565822 | Completed

• 2 other identifiers: 2015_932016-A02050-51
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Malformation

Keywords

Oesophageal Atresia; Congenital Diaphragmatic Hernia; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

interview

OTHER

There are two data collection phases (individual interviews +/- focus groups) with parents of children with esophageal atresia, congenital diaphragmatic hernia or short bowel syndrome.

Other: Interview

Interventions

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.

interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• University of Lille Nord de France: collaborator

Study Sites (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Location

MeSH Terms

Conditions

Congenital Abnormalities; Esophageal Atresia; Hernias, Diaphragmatic, Congenital; Short Bowel Syndrome

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laurent Michaud, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 21, 2018
• Study Start: December 15, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

FR (1)