An observational study in Esophageal Atresia, sponsored by University of Sao Paulo General Hospital. Not yet recruiting at 1 site in Brazil. Open to participants aged 1 Minute to 12 Months. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by University of Sao Paulo General Hospital · Observational
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.
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.
37 studies on the registry are indexed under Esophageal Atresia; 12 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 50 across 19 observational studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients lost to follow-up before reaching 12 months of age.
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.
All-cause mortality within the first year of life
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.
Time frame: From birth until 12 months of age
Surgical complications after primary repair of distal fistula
Incidence of anastomotic dehiscence, stricture, and recurrent fistula among neonates with distal tracheoesophageal fistula undergoing primary surgical repair.
Time frame: From surgery until 12 months of age
Incidence of postoperative complications among premature vs. term neonates with esophageal atresia
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.
Time frame: From birth until 12 months of age
Mortality rate among premature vs. term neonates with esophageal atresia
All-cause mortality will be compared between premature (\<37 weeks gestational age) and term infants.
Time frame: From birth until 12 months of age
Incidence of postoperative sepsis among neonates with esophageal atresia
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.
Time frame: From surgery until 12 months of age
Incidence of postoperative complications among neonates with long-gap esophageal atresia
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.
Time frame: From surgery until 12 months of age
Incidence of mortality among neonates with long-gap esophageal atresia
Number and percentage of neonates with long-gap esophageal atresia who die within 12 months after surgery will be reported.
Time frame: From surgery until 12 months of age
Incidence of complications among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)
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.
Time frame: From birth until 12 months of age
Mortality rate among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)
All-cause mortality will be compared between neonates with congenital anomalies (cardiac malformations or VACTERL association) and those without.
Time frame: From birth until 12 months of age
Plan to share: No
Start is estimated for Nov 2025; primary completion for Nov 2027, 24 months later.
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This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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