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Search / Trial NCT06335862

Primary Posterior Tracheopexy Prevents Tracheal Collapse

Launched by UMC UTRECHT · Mar 21, 2024

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

Oesophageal Atresia Tracheomalacia Primary Posterior Tracheopexy Respiratory Morbidity

ClinConnect Summary

Rationale:

A congenital blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), is very often accompanied by a weakened windpipe (trachea). This is known as tracheomalacia (TM) and entails that the windpipe collapses during expiration. Severe TM can cause increased respiratory morbidity, including frequent respiratory tract infections and blue spells, that can potentially progress to respiratory arrest. Respiratory morbidity poses a significant burden on OA patients, both in the short term and over the course of long-term follow-up. When severe TM is identified, surgical interventio...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with a confirmed diagnosis of OA with a distal TOF
  • Tracheomalacia
  • Written informed consent by both parents or legal representatives
  • Exclusion Criteria:
  • Patients with OA without a distal TOF
  • Premature neonates \<34 weeks
  • Endotracheal tube size \< 3.0
  • Cormack score 3 or 4 as scored by either the otolaryngologist, anesthesiologist, or neonatal/pediatric intensive care specialist
  • Patients with a cyanotic cor vitium

About Umc Utrecht

UMC Utrecht is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research and high-quality patient care. As a prominent sponsor of clinical trials, UMC Utrecht leverages its extensive expertise in translational medicine and collaboration with various stakeholders to advance medical knowledge and improve therapeutic outcomes. The institution emphasizes ethical conduct and rigorous scientific standards, ensuring that all research activities contribute meaningfully to the global healthcare landscape. Through its robust clinical trial infrastructure, UMC Utrecht plays a vital role in facilitating the development of new treatments and enhancing patient wellbeing.

Locations

Utrecht, , Netherlands

London, , United Kingdom

Rotterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

John Vlot, MD, PhD

Principal Investigator

Erasmus Medical Center

Jan F Svensson, MD, PhD

Principal Investigator

Karolinska University Hospital

Colin Butler, MD, PhD

Principal Investigator

Great Ormond Street Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported