Brazilian Multicenter Study on Esophageal Atresia (NEOBRA-EA)

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Esophageal Atresia

Study type: Observational

Funder types: Other

Identifiers

NCT07210736

85624924.8.1001.0068

Details and patient eligibility

About

Esophageal atresia is a congenital malformation where the esophagus does not form properly, often associated with a tracheoesophageal fistula. This condition requires complex surgical treatment and intensive neonatal care. Survival has improved worldwide, but results from other countries cannot be directly applied to Brazil due to differences in health resources. This study will gather data from 72 neonatal centers across Brazil to better understand the characteristics, treatments, complications, and outcomes of newborns with esophageal atresia. The goal is to identify factors associated with complications and mortality, and to generate national evidence that can guide better care and improve survival and quality of life.

Full description

Esophageal atresia is a congenital malformation characterized by an interruption of the esophageal lumen, frequently associated with a tracheoesophageal fistula. Although survival has significantly improved over the past decades in high-income countries, outcomes remain heterogeneous, and the results from international registries cannot be directly extrapolated to the Brazilian context due to regional differences in health system resources, neonatal intensive care, and surgical practice. At present, Brazil lacks a comprehensive national study evaluating the epidemiology, management, and outcomes of neonates with esophageal atresia.

The present multicenter project represents the first nationwide collaboration dedicated to this condition. Seventy-two neonatal centers across Brazil will contribute data, creating a large national cohort that encompasses both retrospective and prospective cases.

Data collection will be standardized and managed using the REDCap platform (Research Electronic Data Capture), with local entry validated centrally at the coordinating center. Variables collected will include prenatal and perinatal information, associated anomalies, anatomical classification of the atresia, diagnostic procedures performed, intraoperative surgical details, postoperative course, complications, and mortality. Particular attention will be given to factors such as prematurity, congenital heart disease, VACTERL association, and "long-gap" esophageal atresia, as these conditions are expected to have significant impact on outcomes.

The study aims to describe the current Brazilian panorama of esophageal atresia, focusing on short- and mid-term outcomes, including mortality within the first year of life, early complications such as anastomotic leakage and sepsis, and late complications including strictures and recurrent fistulas. A multivariate statistical analysis will be performed to identify predictors of adverse outcomes and to compare the results of different treatment strategies adopted across participating centers.

This initiative is expected to provide unprecedented epidemiological and clinical insights into esophageal atresia in Brazil. By combining the expertise and data of multiple neonatal units across diverse regions, the study will generate robust evidence to guide best practices, inform clinical guidelines, and support improvements in neonatal surgical care. Ultimately, the findings have the potential to improve survival and quality of life for Brazilian neonates affected by this challenging congenital condition.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 minute to 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Single group

Description:

Neonates diagnosed with esophageal atresia (with or without tracheoesophageal fistula) admitted to one of 72 participating neonatal centers in Brazil between January 2025 and December 2026. Eligible patients include those born in, or transferred to, a participating center within the first 15 days of life. All patients will be managed according to the treating institution's standard clinical and surgical practice.