Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT07209956
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etude PROTECT : Prognostic Role of Tapse Evaluation in Children's bronchioliTis
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Evaluation de la Valeur Pronostique du TAPSE (Tricuspid Plane Annular Systolic Excursion) Dans la Bronchiolite aigüe sévère Chez l'Enfant hospitalisé en réanimation ou Soins Continus pédiatriques
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
Brief Summary:
In this prospective study, we aim to evaluate the association between an echocardiographic marker of right ventricular systolic function, the TAPSE (Tricuspid Annular Plane Systolic Excursion), and poor outcome in patients admitted to Pediatric Intensive Care Unit (PICU) for Acute Bronchiolitis (AB).
Detailed Description:
During the winter season, acute bronchiolitis is the leading cause of PICU admissions among children under the age of 2 years old, worldwide. Indeed, it is estimated that 10% of children hospitalized for AB will require intensive care, with lengths of stay ranging from several days to several weeks. It is therefore crucial to identify those patients at highest risk of severe disease in order to provide the best management options and potentially decrease morbidity. Recently, the prognostic value of the TAPSE (Tricuspid Annular Plane Systolic Excursion), a marker of right ventricle systolic dysfunction, has been demonstrated in adults suffering from SARS-Cov-2 pneumoniae. Indeed, several studies identify a decrease in TAPSE as a marker associated with an increased mortality among patients hospitalized in ICU with SARS Cov-2 pneumoniae. Moreover, some pediatric studies suggest that pulmonary pressures and right ventricular function could be impaired in AB, and thus associated with a less favorable outcome. None of these studies has specifically investigated the TAPSE as a predictor of severity in AB. To address this question, we plan to conduct a prospective study among children admitted to PICU with AB, and evaluate the association between the TAPSE value at PICU admission, and the PICU length of stay. Patients included in the study, will undergo a systematic echocardiographic assessment with measurement of the TAPSE, within the first 36 hours of admission in PICU for AB. They will then be followed until discharge of hospital, or the occurrence of death, or until the end of the inclusion period. If, during the follow-up period, intubation for invasive ventilation is required, a second echocardiographic assessment will be performed, with measurement of the TAPSE, in order to compare it to the initial value, in secondary analysis for exploratory purposes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: