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

Conditions
Congenital interrupted esophagus
esophageal atresia
10018018
10018008
10010613
Registration Number
NL-OMON53490
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
10
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

Patients with EA types A, B and E, 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome parameter is the practicability of the fLTB, which will be<br /><br>determined by assessing the number of fLTB*s that could be completed and the<br /><br>number that were of sufficient quality for the otolaryngologists to assess the<br /><br>extent of TM. The fLTB will be deemed practicable if 7 out of 10 procedures<br /><br>(70%) were performed completely and were also of sufficient quality to be<br /><br>assessed systematically. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>There are no secondary study parameters. </p><br>
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