How being told before versus after birth affects parents' post‑traumatic reactions after their baby's esophageal 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 "

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
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Lille (Academic / other)
• Locations: 1 site (Lille)
• Trial ID: NCT04911036 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Lille

• 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

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