Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204367
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-12
First Post:
2024-01-02
Brief Title:
Evaluation of Lung Ultrasonography Findings in Newborns With Respiratory Syncytial Virus Bronchiolitis
Sponsor:
Kırıkkale University
Organization:
Kırıkkale University
Study Overview
Official Title:
Evaluation of Lung Ultrasonography Findings in Newborns With Respiratory Syncytial Virus Bronchiolitis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
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:
None
Brief Summary:
Respiratory Syncytial Virus RSV is a seasonal highly contagious pathogen belonging to the Pneumoviridae genus orthopneumovirus a family of negative-strand RNA viruses Lung ultrasonography Today it has become frequently used in neonatal intensive care units because it is a diagnostic useful harmless radiation-free bedside reproducible and practical method The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors which are frequently encountered
Detailed Description:
Respiratory Syncytial Virus RSV is a type of negative-strand RNA viruses It is a seasonal highly contagious pathogen belonging to the family Pneumoviridae genus orthopneumovirus RSV is a common cause of respiratory disease throughout life but is associated with significant morbidity and mortality especially in infants and older adults
RSV infections account for approximately 60 to 80 of bronchiolitis in infancy and 40 of pediatric pneumonias
Bronchiolitis is an acute lower respiratory tract infection that affects children under one or two years of age and is the most common cause of hospitalization according to American Academy of Pediatrics AAP guidelines Diagnostic criteria for bronchiolitis are based on clinical history and examination
Lung ultrasonography LUS was first used in adults in 1995 and in the last decade lung ultrasound has proven to be a useful diagnostic tool in many pediatric and neonatal diseases and its application and benefit in the treatment of bronchiolitis has been reported Since AUS allows bedside assessment of the subpleural lung for density thus reducing the quantitative ratio of airspace and space it is reasonable to expect that a combination of clinical and ultrasound parameters may be useful Studies have shown that qualitative and quantitative lung ultrasound findings suggest a relationship with the severity of bronchiolitis and are useful in the follow-up of patients
Caiulo et al They showed that AUS is a valuable tool in the diagnosis of bronchiolitis
However data on lung ultrasound in newborns with viral lower respiratory tract infections are quite limited
Lung ultrasonography Today it has become frequently used in neonatal intensive care units because it is a diagnostic useful harmless radiation-free bedside reproducible and practical method In our clinic lung ultrasonography is performed on babies hospitalized with respiratory distress Images will be obtained using the linear probe of the device to be used for AUS Brat et al AUS scoring specified in the studies of Raimondi et al and Raimondi et al will be used
Accordingly both lungs will be evaluated as three areas on the right and left anterior upper anterior lower and lateral and will be scored separately Parasternal with anterior axillary line in front The area between the line is divided into two by the line passing from the nipple The upper part is considered as the upper anterior region and the lower part is considered as the lower anterior region The area in the middle of the anterior and posterior axillary lines is called the lateral region
is evaluated Each field is given a score of 0 to 3 If there were A lines 0 points were given If there were more than 3 B lines in an area 1 point was given If the B lines were very dense and there was no A line it was evaluated as white lung and 2 points were given If there was a consolidation image in AUS 3 points were given The total score was evaluated as a maximum of 18 In this study newborn babies who were admitted and admitted to the Neonatal Intensive Care Unit of Kırıkkale University Faculty of Medicine Hospital with symptoms of viral lower respiratory tract diseases between 18122023 and 01062023 were clinically diagnosed with 40 of their O2 need at the 24th hour of hospitalization Lung ultrasonography was planned to be performed in cases where the patient was overweight andor required pressure or was intubated and at the time of discharge Demographic characteristics symptoms all routine laboratory and radiological imaging of newborn babies and additional pathogen or pathogens will be obtained from the file information The parameters to be recorded are shown in the Case Report Form The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors which are frequently encountered
RSV infections account for approximately 60 to 80 of bronchiolitis in infancy and 40 of pediatric pneumonias
Bronchiolitis is an acute lower respiratory tract infection that affects children under one or two years of age and is the most common cause of hospitalization according to American Academy of Pediatrics AAP guidelines Diagnostic criteria for bronchiolitis are based on clinical history and examination
Lung ultrasonography LUS was first used in adults in 1995 and in the last decade lung ultrasound has proven to be a useful diagnostic tool in many pediatric and neonatal diseases and its application and benefit in the treatment of bronchiolitis has been reported Since AUS allows bedside assessment of the subpleural lung for density thus reducing the quantitative ratio of airspace and space it is reasonable to expect that a combination of clinical and ultrasound parameters may be useful Studies have shown that qualitative and quantitative lung ultrasound findings suggest a relationship with the severity of bronchiolitis and are useful in the follow-up of patients
Caiulo et al They showed that AUS is a valuable tool in the diagnosis of bronchiolitis
However data on lung ultrasound in newborns with viral lower respiratory tract infections are quite limited
Lung ultrasonography Today it has become frequently used in neonatal intensive care units because it is a diagnostic useful harmless radiation-free bedside reproducible and practical method In our clinic lung ultrasonography is performed on babies hospitalized with respiratory distress Images will be obtained using the linear probe of the device to be used for AUS Brat et al AUS scoring specified in the studies of Raimondi et al and Raimondi et al will be used
Accordingly both lungs will be evaluated as three areas on the right and left anterior upper anterior lower and lateral and will be scored separately Parasternal with anterior axillary line in front The area between the line is divided into two by the line passing from the nipple The upper part is considered as the upper anterior region and the lower part is considered as the lower anterior region The area in the middle of the anterior and posterior axillary lines is called the lateral region
is evaluated Each field is given a score of 0 to 3 If there were A lines 0 points were given If there were more than 3 B lines in an area 1 point was given If the B lines were very dense and there was no A line it was evaluated as white lung and 2 points were given If there was a consolidation image in AUS 3 points were given The total score was evaluated as a maximum of 18 In this study newborn babies who were admitted and admitted to the Neonatal Intensive Care Unit of Kırıkkale University Faculty of Medicine Hospital with symptoms of viral lower respiratory tract diseases between 18122023 and 01062023 were clinically diagnosed with 40 of their O2 need at the 24th hour of hospitalization Lung ultrasonography was planned to be performed in cases where the patient was overweight andor required pressure or was intubated and at the time of discharge Demographic characteristics symptoms all routine laboratory and radiological imaging of newborn babies and additional pathogen or pathogens will be obtained from the file information The parameters to be recorded are shown in the Case Report Form The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors which are frequently encountered
Study Oversight
Has Oversight DMC:
None
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?:
None