Brazilian Multicenter Study on Esophageal Atresia

Not yet recruiting

• Conditions: Esophageal Atresia

• Registration Number: NCT07210736
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality within the first year of life	From birth until 12 months of age	Mortality from any cause in neonates with esophageal atresia, with or without tracheoesophageal fistula, who undergo standard surgical and neonatal management at participating centers. Mortality will include early deaths during initial hospitalization as well as late deaths up to 12 months of age.

Secondary Outcome Measures

Name	Time	Method
Surgical complications after primary repair of distal fistula	From surgery until 12 months of age	Incidence of anastomotic dehiscence, stricture, and recurrent fistula among neonates with distal tracheoesophageal fistula undergoing primary surgical repair.
Incidence of postoperative complications among premature vs. term neonates with esophageal atresia	From birth until 12 months of age	Number and percentage of neonates experiencing major postoperative complications (including anastomotic leakage, sepsis, stricture, or recurrent fistula) will be compared between premature (\<37 weeks gestational age) and term infants.
Mortality rate among premature vs. term neonates with esophageal atresia	From birth until 12 months of age	All-cause mortality will be compared between premature (\<37 weeks gestational age) and term infants.
Incidence of postoperative sepsis among neonates with esophageal atresia	From surgery until 12 months of age	Number and percentage of neonates experiencing postoperative sepsis will be reported. Sepsis will be defined according to Phoenix sepsis criteria for sepsis and septic shock.
Incidence of postoperative complications among neonates with long-gap esophageal atresia	From surgery until 12 months of age	Number and percentage of neonates with long-gap esophageal atresia experiencing major postoperative complications (including anastomotic leakage, sepsis, stricture, or recurrent fistula) will be reported.
Incidence of mortality among neonates with long-gap esophageal atresia	From surgery until 12 months of age	Number and percentage of neonates with long-gap esophageal atresia who die within 12 months after surgery will be reported.
Incidence of complications among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)	From birth until 12 months of age	Number and percentage of neonates experiencing major postoperative complications will be compared between those with congenital anomalies (cardiac malformations or VACTERL association) and those without.
Mortality rate among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)	From birth until 12 months of age	All-cause mortality will be compared between neonates with congenital anomalies (cardiac malformations or VACTERL association) and those without.

Trial Locations

Locations (1)

Instituto da Crianca e do Adolescente, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo; 🇧🇷 São Paulo, Brazil