How being told before versus after birth affects parents' post‑traumatic reactions after their baby's esophageal atresia surgery
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 "
Run by University Hospital, Lille · NCT04911036 · Data updated 2026-11-12
The study will see if parents who learn about their baby's esophageal atresia before birth have different levels of post‑traumatic reactions than parents who learn after birth, focusing mainly on mothers (with fathers invited to participate) of children aged 12–24 months who had neonatal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | May 6, 2021 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT04911036 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Mothers (and fathers who agree) of a living child aged 12–24 months who underwent neonatal surgery for type 1 or type 3 esophageal atresia, who are French‑speaking, socially insured, and able to consent, are ideal candidates.
✕Probably not a fit
Parents of children with chromosomal abnormalities or polymalformative syndromes, non‑French speakers, minors, pregnant women, people under legal protection, or those deprived of liberty are excluded and unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a national, multicentre (34 centres) cross‑sectional observational study using questionnaires to compare post‑traumatic reaction levels in parents who received an antenatal versus a postnatal diagnosis of esophageal atresia. Participants complete standardized measures, including perinatal posttraumatic stress questionnaires, at a single time point when their child is 12–24 months old. The primary analysis compares mothers' reported symptoms by timing of diagnosis, with an ancillary analysis among fathers who agree to participate. Exclusion criteria remove parents of children with chromosomal or polymalformative syndromes and those unable to consent or complete French questionnaires.
Why it matters
Potential benefit: If successful, the results could guide when and how to offer tailored psychological support to parents to reduce long‑term distress.
How similar studies have gone: Previous research has documented post‑traumatic symptoms in parents of NICU infants, but directly comparing antenatal versus postnatal diagnosis in esophageal atresia is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hop Jeanne de Flandre Chu Lille
Lille, France Recruiting
Study contacts
- Principal investigator: Véronique Debarge, MD,PhD — University Hospital, Lille
- Study coordinator: Véronique Debarge, MD,PhD
- Email: veronique.DEBARGE@chru-lille.fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.