Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "

NCT04911036 | Recruiting

• 2 other identifiers: 2019_262020-A00255-34
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's EA diagnosis. An ancillary study will be carried out among the fathers present who agree to participate in the study.

Conditions

Atresia, Esophageal

Keywords

Esophageal atresia; post-traumatic reactions; early accompaniment; Perinatal Posttraumatic Stress Disorder Questionnaire; cross-sectional study in psychology

Outcome Measures

Primary Outcomes (1)

• Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)

  The score PPQ derived from this instrument corresponds to the number of items (there are 14) to which the parent responded positively (theoretical spread: 0-14 points)

  at 2 months

Secondary Outcomes (4)

• Percentage of mothers with Score PPQ >5

  at 2 months

• Questionnaire on early support

  at 2 months

• Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers

  at 2 months

• Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers

  at 2 months

Study Arms (2)

Mothers and/or fathers with an antenatal diagnosis

Other: Questionnaires

Mothers and/or fathers with a postnatal diagnosis

Other: Questionnaires

Interventions

Questionnaires OTHER

Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire

Mothers and/or fathers with a postnatal diagnosis; Mothers and/or fathers with an antenatal diagnosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Be a mother and/or a father of a living child aged between 12 and 24 months who has undergone neonatal surgery following a diagnosis of type 1 or type 3 EA
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Be a mother and/or a father of a living child aged between 12 and 24 months who has undergone neonatal surgery following a diagnosis of type 1 or type 3 EA

You may qualify if:

• Be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 EA;
• Not to have objected to participating in the study (information and non-objection form signed by the investigator);
• To be socially insured.

You may not qualify if:

• Woman or man whose child with AO has a chromosomal abnormality;
• Woman or man whose child with AO has a polymalformative syndrome;
• Female or male minor ;
• Pregnant woman;
• Woman or man who does not speak French;
• Woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship);
• Woman or man deprived of liberty.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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

• Véronique Debarge, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Debarge, MD,PhD

CONTACT

0320445962; veronique.DEBARGE@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: May 6, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)