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NCT Number: NCT04911036

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 "

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)

    Time frame: at 2 months

    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)

Secondary outcomes

  1. Percentage of mothers with Score PPQ >5

    Time frame: at 2 months

  2. Questionnaire on early support

    Time frame: at 2 months

    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.

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

    Time frame: at 2 months

    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.

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

    Time frame: at 2 months

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique Debarge, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: DANAO

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2021
Registry last updated
Dec 23, 2025

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.

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