Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04911036
Acronym
DANAO
Enrollment
240
Registered
2021-06-02
Start date
2021-05-06
Completion date
2027-05-31
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atresia, Esophageal

Keywords

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

Brief 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.

Interventions

OTHERQuestionnaires

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)at 2 monthsThe 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

MeasureTime frameDescription
Percentage of mothers with Score PPQ >5at 2 months
Questionnaire on early supportat 2 monthsThis 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.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothersat 2 monthsState-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.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathersat 2 months

Countries

France

Contacts

Primary ContactVéronique Debarge, MD,PhD
veronique.DEBARGE@chru-lille.fr0320445962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026