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Clinical Trials/CTRI/2023/06/054248
CTRI/2023/06/054248
Recruiting
未知

Ambispective cohort study to evaluate the effect of Supraglottoplasty on Tracheomalacia in pediatric patients with Congenital Laryngotracheomalacia

All India Institute of Medical Sciences, New Delhi0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
All India Institute of Medical Sciences, New Delhi
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
All India Institute of Medical Sciences, New Delhi

Eligibility Criteria

Inclusion Criteria

  • •Age group of 1 month \- 5 years with noisy breathing/stridor
  • •Endoscopic confirmation of co\-existing laryngomalacia and tracheomalacia
  • •More than 50% collapse in the trachea during expiration / inspiration on dynamic flexible bronchoscopy.
  • •Any degree of laryngomalacia
  • •Presence of at least two of the following clinical features
  • •1\. Failure to thrive (z\-score of weight for age less than 2\)
  • •2\. 3 or more hospitalizations for LTM related complications
  • •3\. Severe respiratory distress necessitating endotracheal intubation
  • •4\. Episodes of bradycardia/ cyanosis/ apnea due to Laryngotracheomalacia
  • •5\. SPO2 less than 90% at room air without the support of O2/ CPAP

Exclusion Criteria

  • •Laryngeal/ tracheal narrowing due to external compression
  • •Patients not consenting for surgery
  • •Severe neurological/ cardiac comorbidities / poor pulmonary reserve

Outcomes

Primary Outcomes

Not specified

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