Atresia, EsophagealDANAONCT04911036
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 of Atresia, Esophageal, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atresia, Esophageal
- What is being tested?
- Questionnaires
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2021to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
0320445962
About this study
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
- Being tested
- Questionnaires
- Keywords
- Esophageal atresia, post-traumatic reactions, early accompaniment, Perinatal Posttraumatic Stress Disorder Questionnaire, cross-sectional study in psychology
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Mothers and/or fathers with an antenatal diagnosis | Not described Receives: Other: Questionnaires | |
| Mothers and/or fathers with a postnatal diagnosis | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 2 months
Secondary outcomes (4)
Percentage of mothers with Score PPQ >5
Measured: 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.
Measured: 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.
Measured: at 2 months
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start6 May 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atresia, EsophagealStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Debarge, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911036
- Sponsor's protocol ID
- 2019_26
- Other IDs
- 2020-A00255-34
- Acronym
- DANAO
- Status last verified
- Dec 2025
- First submitted
- 27 May 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 "
- ClinicalTrials.gov ID
- NCT04911036
- Acronym / sponsor ID
- DANAO / 2019_26
- Conditions
- Atresia, Esophageal
- Keywords
- Esophageal atresia, post-traumatic reactions, early accompaniment, Perinatal Posttraumatic Stress Disorder Questionnaire, cross-sectional study in psychology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers and/or fathers with an antenatal diagnosis | – | Other: Questionnaires |
| Mothers and/or fathers with a postnatal diagnosis | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPerinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire | Other | Mothers and/or fathers with a postnatal diagnosis, Mothers and/or fathers with an antenatal diagnosis |
Primary outcome
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)
4 secondary outcomes
Percentage of mothers with Score PPQ >5
Time frame: at 2 months
Questionnaire on early support
Time frame: at 2 months
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers
Time frame: at 2 months
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers
Time frame: at 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Véronique Debarge, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atresia, Esophageal, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Debarge, MD,PhD (0320445962 ext. +33, veronique.DEBARGE@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ) (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.