Brazilian Multicenter Study on Esophageal Atresia
ConditionEsophageal Atresia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Single group
Trial outcomes
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.
Time frame
From birth until 12 months of ageSecondary outcomes
1
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 age2
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 age3
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 age4
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 ageSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: