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 "

NCT ID: NCT04911036

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atresia, Esophageal

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers and/or fathers with an antenatal diagnosis

Questionnaires

Intervention Type 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

Questionnaires

Intervention Type OTHER

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

Interventions

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Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique Debarge, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Véronique Debarge, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2020-A00255-34

Identifier Type: OTHER

Identifier Source: secondary_id

2019_26

Identifier Type: -

Identifier Source: org_study_id