Esophageal AtresiaNEOBRA-EANCT07210736
Brazilian Multicenter Study on Esophageal Atresia
An observational study of Esophageal Atresia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 12 months
- Conditions the study is for
- Esophageal Atresia
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Patients lost to follow-up before reaching 12 months of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto da Crianca e do Adolescente, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
São Paulo, 05403000
Ana C Tannuri, MD, PhD, +55 11 99629-1729, ana.tannuri@hc.fm.usp.br
Vinicius C Quintao, MD, MSc, PhD, +55 11 97127-3950, vinicius.quintao@hc.fm.usp.br
About this study
Official title: Evolution of Neonates With Esophageal Atresia in Brazil - A Multicenter Study
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.
Read the 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.
- Conditions
- Esophageal Atresia
- Keywords
- Esophageal atresia, Surgical outcomes, Multicenter, Brazil
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth until 12 months of age
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From birth until 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Cristina Aoun Tannuri, University of Sao Paulo General Hospital
- Investigators
- Ana C Tannuri, MD, PhD, Principal investigator, Hospital das Clínicas HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210736
- Sponsor's protocol ID
- 85624924.8.1001.0068
- Acronym
- NEOBRA-EA
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31396739Lal 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.
PubMed 28599967Tannuri 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.
PubMed 17336187Foker 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.
PubMed 15770584Tobia 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.
PubMed 37043961Koivusalo 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.
PubMed 19207547Aslanabadi 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.
PubMed 19290533Davenport 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.
PubMed 25638610Spitz 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.
PubMed 17011260Goyal 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.
PubMed 16923940Roberts 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.
PubMed 27206060
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Neonates With Esophageal Atresia in Brazil - A Multicenter Study
- ClinicalTrials.gov ID
- NCT07210736
- Acronym / sponsor ID
- NEOBRA-EA / 85624924.8.1001.0068
- Conditions
- Esophageal Atresia
- Keywords
- Esophageal atresia, Surgical outcomes, Multicenter, Brazil
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 minute to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients lost to follow-up before reaching 12 months of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality within the first year of life
Time frame: 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.
8 secondary outcomes
Surgical complications after primary repair of distal fistula
Time frame: From surgery until 12 months of age
Incidence of postoperative complications among premature vs. term neonates with esophageal atresia
Time frame: From birth until 12 months of age
Mortality rate among premature vs. term neonates with esophageal atresia
Time frame: From birth until 12 months of age
Incidence of postoperative sepsis among neonates with esophageal atresia
Time frame: From surgery until 12 months of age
Incidence of postoperative complications among neonates with long-gap esophageal atresia
Time frame: From surgery until 12 months of age
Incidence of mortality among neonates with long-gap esophageal atresia
Time frame: From surgery until 12 months of age
Incidence of complications among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)
Time frame: From birth until 12 months of age
Mortality rate among neonates with vs. without associated congenital anomalies (cardiac or VACTERL components)
Time frame: From birth until 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 31396739Ishimaru 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.
- Background: PubMed 28599967Lal 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.
- Background: PubMed 17336187Tannuri 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.
- Background: PubMed 15770584Foker 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.
- Background: PubMed 37043961Tobia 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.
- Background: PubMed 19207547Koivusalo 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.
- Background: PubMed 19290533Aslanabadi 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.
- Background: PubMed 25638610Davenport 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.
- Background: PubMed 17011260Spitz 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.
- Background: PubMed 16923940Goyal 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.
- Background: PubMed 27206060Roberts 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.
- Individual participant dataSharing planned: No
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Atresia, Esophageal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana C Tannuri, MD, PhD principal investigator
Hospital das Clínicas HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana C Tannuri, MD, PhD (+55 11 99629-1729, ana.tannuri@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within the first year of life (time frame: From birth until 12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210736, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.