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 " (DANAO)

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.

Study Overview

• Status: Recruiting
• Conditions: Atresia, Esophageal
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Véronique Debarge, MD,PhD; Phone Number: +33 0320445962; Email: veronique.DEBARGE@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mothers and/or fathers with an antenatal diagnosis	Other: Questionnaires; Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire
Mothers and/or fathers with a postnatal diagnosis	Other: Questionnaires; Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mothers with Score PPQ >5		at 2 months
Questionnaire on early support	This is a questionnaire co-constructed with the Association Française de l'Atresie de l'œsophage (AFAO) to collect information on the perception of support available or received upon suspicion of an abnormality in the child. It consists of 15 questions. The first eight explore satisfaction with various aspects of early support (information, support, professionals met...). The next seven address parental perceptions regarding information and support. Most of the questions are to be answered on a 5-point Likert scale (e.g., from "Not at all satisfied" to "Very satisfied" or "Never" to "Almost always"), the other questions are closed-ended. Time to complete the test: 5 to 10 minutes.	at 2 months
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers	State-Trait Anxiety Inventory (STAI-TRAIT) SCORE: 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.	at 2 months
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers		at 2 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Véronique Debarge, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Esophageal atresia; post-traumatic reactions; early accompaniment; Perinatal Posttraumatic Stress Disorder Questionnaire; cross-sectional study in psychology
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: 2019_26; 2020-A00255-34 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No