Tracheomalacia in babies after correction of Esophageal Atresia - A First step to reduce respiratory morbidity

Tracheomalacia in babies after correction of Esophageal Atresia - A First step to reduce respiratory morbidity - Tracheomalacia after Esophageal Atresia Correction (TEA study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53490

Enrollment

Registered

2023-05-11

Start date

2023-05-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital interrupted esophagus esophageal atresia

Interventions

After surgical repair of EA, a post-operative fLTB will be carried out right before/during planned extubation. The fLTB will be done through the endotracheal tube at the neonatal or pediatric ICU.

Eligibility

Inclusion criteria

Inclusion criteria: Patients with EA type C and D, Scheduled for surgical EA repair, Written informed consent by both parents or legal representative(s)

Exclusion criteria

Exclusion criteria: Patients with EA types A, B and E, Endotracheal tube size

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is the practicability of the fLTB, which will be determined by assessing the number of fLTB*s that could be completed and the number that were of sufficient quality for the otolaryngologists to assess the extent of TM. The fLTB will be deemed practicable if 7 out of 10 procedures (70%) were performed completely and were also of sufficient quality to be assessed systematically.	—

Measure

Time frame

The primary outcome parameter is the practicability of the fLTB, which will be determined by assessing the number of fLTB*s that could be completed and the number that were of sufficient quality for the otolaryngologists to assess the extent of TM. The fLTB will be deemed practicable if 7 out of 10 procedures (70%) were performed completely and were also of sufficient quality to be assessed systematically.

—

Secondary

Measure	Time frame
There are no secondary study parameters.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)