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RecruitingNCT04911036DANAOUpdated Dec 23, 2025

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 "

An observational study in Atresia, Esophageal, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started May 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atresia, Esophageal

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Keywords

  • Esophageal atresia
  • post-traumatic reactions
  • early accompaniment
  • Perinatal Posttraumatic Stress Disorder Questionnaire
  • cross-sectional study in psychology
03

In context

Esophageal Atresia

37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.

This study's planned enrollment of 240 is above the median of 50 across 19 observational studies indexed under Esophageal Atresia.

Browse Esophageal Atresia studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mothers and/or fathers with an antenatal diagnosis

    Other: Questionnaires

  • Mothers and/or fathers with a postnatal diagnosis

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

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

06

What researchers measure

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)

    Time frame: at 2 months

Secondary outcomes

  1. Percentage of mothers with Score PPQ >5

    Time frame: at 2 months

  2. 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.

    Time frame: at 2 months

  3. 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.

    Time frame: at 2 months

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

    Time frame: at 2 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for May 2027, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2021
First posted
Jun 2, 2021
StartActual
May 6, 2021
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Dec 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04911036
Responsible party
Sponsor
First posted
Jun 2, 2021
Start date
May 6, 2021
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Dec 23, 2025

Study contacts

Véronique Debarge, MD,PhD
Contact
veronique.DEBARGE@chru-lille.fr
0320445962 ext. +33
Véronique Debarge, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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