Brazilian Multicenter Study on Esophageal Atresia

NCT07210736 | Not Yet Recruiting

• 1 other identifier: 85624924.8.1001.0068
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Atresia

Keywords

Esophageal atresia; Surgical outcomes; Multicenter; Brazil

Outcome Measures

Primary Outcomes (1)

• 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.

  From birth until 12 months of age

Secondary Outcomes (8)

• Surgical complications after primary repair of distal fistula

  From surgery until 12 months of age

• Incidence of postoperative complications among premature vs. term neonates with esophageal atresia

  From birth until 12 months of age

• Mortality rate among premature vs. term neonates with esophageal atresia

  From birth until 12 months of age

• Incidence of postoperative sepsis among neonates with esophageal atresia

  From surgery until 12 months of age

• Incidence of postoperative complications among neonates with long-gap esophageal atresia

  From surgery until 12 months of age

Study Arms (1)

Single group

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.

Eligibility Criteria

• Age: 1 Minute - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patients lost to follow-up before reaching 12 months of age.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403000, Brazil

Location

Related Publications (11)

• Ishimaru T, Fujiogi M, Michihata N, Matsui H, Fushimi K, Kawashima H, Fujishiro J, Yasunaga H. Impact of congenital heart disease on outcomes after primary repair of esophageal atresia: a retrospective observational study using a nationwide database in Japan. Pediatr Surg Int. 2019 Oct;35(10):1077-1083. doi: 10.1007/s00383-019-04542-w. Epub 2019 Aug 8.

  PMID: 31396739 BACKGROUND

• Lal DR, Gadepalli SK, Downard CD, Ostlie DJ, Minneci PC, Swedler RM, Chelius TH, Cassidy L, Rapp CT, Billmire D, Bruch S, Burns RC, Deans KJ, Fallat ME, Fraser JD, Grabowski J, Hebel F, Helmrath MA, Hirschl RB, Kabre R, Kohler J, Landman MP, Leys CM, Mak GZ, Raque J, Rymeski B, Saito JM, St Peter SD, von Allmen D, Warner BW, Sato TT; Midwest Pediatric Surgery Consortium. Challenging surgical dogma in the management of proximal esophageal atresia with distal tracheoesophageal fistula: Outcomes from the Midwest Pediatric Surgery Consortium. J Pediatr Surg. 2018 Jul;53(7):1267-1272. doi: 10.1016/j.jpedsurg.2017.05.024. Epub 2017 Jun 1.

  PMID: 28599967 BACKGROUND

• Tannuri U, Maksoud-Filho JG, Tannuri AC, Andrade W, Maksoud JG. Which is better for esophageal substitution in children, esophagocoloplasty or gastric transposition? A 27-year experience of a single center. J Pediatr Surg. 2007 Mar;42(3):500-4. doi: 10.1016/j.jpedsurg.2006.10.042.

  PMID: 17336187 BACKGROUND

• Foker JE, Kendall TC, Catton K, Khan KM. A flexible approach to achieve a true primary repair for all infants with esophageal atresia. Semin Pediatr Surg. 2005 Feb;14(1):8-15. doi: 10.1053/j.sempedsurg.2004.10.021.

  PMID: 15770584 BACKGROUND

• Tobia A, Luque CG, Leitmeyer K, Dorling M, Chadha NK. Endoscopic treatment in pediatric patients with recurrent and H-type tracheoesophageal fistulas - A systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2023 May;168:111541. doi: 10.1016/j.ijporl.2023.111541. Epub 2023 Mar 31.

  PMID: 37043961 BACKGROUND

• Koivusalo A, Pakarinen MP, Rintala RJ. Anastomotic dilatation after repair of esophageal atresia with distal fistula. Comparison of results after routine versus selective dilatation. Dis Esophagus. 2009;22(2):190-4. doi: 10.1111/j.1442-2050.2008.00902.x. Epub 2008 Dec 22.

  PMID: 19207547 BACKGROUND

• Aslanabadi S, Jamshidi M, Tubbs RS, Shoja MM. The role of prophylactic chest drainage in the operative management of esophageal atresia with tracheoesophageal fistula. Pediatr Surg Int. 2009 Apr;25(4):365-8. doi: 10.1007/s00383-009-2345-7. Epub 2009 Mar 17.

  PMID: 19290533 BACKGROUND

• Davenport M, Rothenberg SS, Crabbe DC, Wulkan ML. The great debate: open or thoracoscopic repair for oesophageal atresia or diaphragmatic hernia. J Pediatr Surg. 2015 Feb;50(2):240-6. doi: 10.1016/j.jpedsurg.2014.11.008. Epub 2014 Nov 7.

  PMID: 25638610 BACKGROUND

• Spitz L. Esophageal atresia. Lessons I have learned in a 40-year experience. J Pediatr Surg. 2006 Oct;41(10):1635-40. doi: 10.1016/j.jpedsurg.2006.07.004.

  PMID: 17011260 BACKGROUND

• Goyal A, Jones MO, Couriel JM, Losty PD. Oesophageal atresia and tracheo-oesophageal fistula. Arch Dis Child Fetal Neonatal Ed. 2006 Sep;91(5):F381-4. doi: 10.1136/adc.2005.086157.

  PMID: 16923940 BACKGROUND

• Roberts K, Karpelowsky J, Fitzgerald DA, Soundappan SS. Outcomes of oesophageal atresia and tracheo-oesophageal fistula repair. J Paediatr Child Health. 2016 Jul;52(7):694-8. doi: 10.1111/jpc.13211. Epub 2016 May 20.

  PMID: 27206060 BACKGROUND

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ana C Tannuri, MD, PhD

  Hospital das Clínicas HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Tannuri, MD, PhD

CONTACT

+55 11 99629-1729; ana.tannuri@hc.fm.usp.br

Vinicius C Quintao, MD, MSc, PhD

CONTACT

+55 11 97127-3950; vinicius.quintao@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 7, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)