Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reac… (NCT04911036) | Clinical Trial Compass
RecruitingNot Applicable
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 "
France240 participantsStarted 2021-05-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.