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Brazil launches massive study to save babies with rare birth defect

NCT ID NCT07210736

Knowledge-focused Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will collect information from 1,000 newborns with esophageal atresia (a birth defect where the esophagus doesn't form correctly) across 72 hospitals in Brazil. Researchers aim to understand what factors lead to complications and death, and to find ways to improve treatment and survival. The study does not test a new treatment but gathers real-world data to guide better care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of neonates diagnosed with esophageal atresia admitted to 72 participating neonatal centers across Brazil. Eligible infants include those identified antenatally or perinatally and confirmed by clinical and diagnostic evaluation shortly after birth. Both term and preterm neonates will be included, and data on associated congenital anomalies will be collected. The cohort is designed to reflect the full clinical spectrum of esophageal atresia encountered in Brazilian neonatal surgical practice, including cases with distal fistula, isolated atresia without fistula, long-gap esophageal atresia, and patients with complex associated malformations such as congenital heart disease and VACTERL association.

Ages

1 minute to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Neonates with a confirmed diagnosis of esophageal atresia of any anatomical type (with or without tracheoesophageal fistula). * Birth in, or transfer to, one of the participating neonatal centers within the first 15 days of life. Exclusion Criteria: \- Patients lost to follow-up before reaching 12 months of age.

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Conditions

The condition(s) this trial relates to.

esophageal atresia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal atresia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Instituto da Crianca e do Adolescente, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

    São Paulo, 05403000, Brazil

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