Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314789
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
The Use of Lung Ultrasonography in the Delivery Room in Neonates
Sponsor:
Kırıkkale University
Organization:
Kırıkkale University
Study Overview
Official Title:
The Role and Importance of Lung Ultrasound Score Used in the Delivery Room in the Early Diagnosis of Respiratory Morbidities in Newborns
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
LUSIN
Brief Summary:
Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic useful harmless radiation-free bedside reproducible and practical method 1 2 In our clinic lung ultrasonography imaging is performed in infants hospitalized with respiratory distress
Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome RDS pneumonia neonatal transient tachypnea NTRT congenital pneumonia meconium aspiration syndrome and pneumothorax 1 2 The reliability and specificity of AUS imaging especially in the diagnosis of NTRT have been proven in many studies
AUS imaging has become an objective value by scoring today Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone both lungs will be evaluated as three areas on the right and left anterior upper anterior lower and lateral and scored separately Anteriorly the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple Above is considered as the upper anterior region and below as the lower anterior region The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region Each area is scored from 0 to 3 points If A lines are present 0 points are given if there are more than 3 B lines in an area 1 point is given if B lines are very dense and there are no A lines it is considered as white lung and 2 points are given If there is a consolidation image on AUS 3 points were given The maximum total score was 18 89 Figure 1
In this study both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed at postnatal 2nd 6th and 24th hours in the intensive care unit for inpatients and in the maternal ward for maternal patients The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants The secondary aim was to investigate the value of the course of AUS scores at postnatal 2 6 and 24 hours in predicting the respiratory prognosis of the newborn infant
Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome RDS pneumonia neonatal transient tachypnea NTRT congenital pneumonia meconium aspiration syndrome and pneumothorax 1 2 The reliability and specificity of AUS imaging especially in the diagnosis of NTRT have been proven in many studies
AUS imaging has become an objective value by scoring today Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone both lungs will be evaluated as three areas on the right and left anterior upper anterior lower and lateral and scored separately Anteriorly the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple Above is considered as the upper anterior region and below as the lower anterior region The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region Each area is scored from 0 to 3 points If A lines are present 0 points are given if there are more than 3 B lines in an area 1 point is given if B lines are very dense and there are no A lines it is considered as white lung and 2 points are given If there is a consolidation image on AUS 3 points were given The maximum total score was 18 89 Figure 1
In this study both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed at postnatal 2nd 6th and 24th hours in the intensive care unit for inpatients and in the maternal ward for maternal patients The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants The secondary aim was to investigate the value of the course of AUS scores at postnatal 2 6 and 24 hours in predicting the respiratory prognosis of the newborn infant
Detailed Description:
Lung ultrasonography LUS was first used in adults in 1995 and has been used in neonatology and pediatrics in recent years and has become increasingly widespread Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic useful harmless radiation-free bedside reproducible and practical method 1 2 In our clinic lung ultrasonography imaging is performed in infants hospitalized with respiratory distress
Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome RDS pneumonia neonatal transient tachypnea NTRT congenital pneumonia meconium aspiration syndrome and pneumothorax 1 2 The reliability and specificity of AUS imaging especially in the diagnosis of RDS have been proven in many studies 123 The diagnosis of RDS on lung ultrasonography is made by visualization of the transition zone double lung point 3 In addition white lung appearance in RDS absence of pleural motion and barcode appearance in M mode in the presence of pneumothorax one of the air leakage syndromes and hepatizationconsolidation appearance in pneumonia are among ultrasonographic findings 13
In infants whose lung ultrasound findings are compatible with RDS and who clinically require surfactant surfactant therapy is given in a shorter time without waiting for chest radiography In a study involving 40 patients diagnosed with RDS it was found that there was a significant improvement ultrasonographically in the 4th hour of surfactant treatment and in another study it was shown that chest radiography was dramatically reduced with the use of AUS 4 5 In the light of this information we see that the use of AUS is becoming increasingly widespread in newborns AUS imaging has now become an objective value by scoring With these scores the relationship between the diagnosis of the disease and the score has been tried to be determined and related studies have been conducted 67 Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone The AUS scoring described in the studies of Brat et al and Raimondi et al 89 Accordingly both lungs will be evaluated as three areas on the right and left anterior superior anterior inferior and lateral and scored separately Anteriorly the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple Above is considered as the upper anterior region and below as the lower anterior region The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region Each area is scored from 0 to 3 points If A lines are present 0 points are given if there are more than 3 B lines in an area 1 point is given if B lines are very dense and there are no A lines it is considered as white lung and 2 points are given If there is a consolidation image on AUS 3 points were given The maximum total score was 18 89 Figure 1
The transition from fetal to extrauterine life requires numerous rapid organ adaptations Clearance of fetal lung fluid surfactant secretion and the onset of steady breathing occur during pulmonary adaptation and changes in blood flow increased cardiac output and pulmonary vasodilation occur for the cardiovascular transition 10 This period typically lasts for two hours During this period placental breathing is replaced by spontaneous breathing When there is a delay in transition during this adaptation process tachypnea and moaning may be observed This process should be distinguished from transient tachypnea wet lung of the newborn In case of respiratory distress that persists after the first two hours postnatally the transition delay is avoided 10 Transient tachypnea of the newborn is considered as a possible diagnosis If there is a risk factor or respiratory distress persists and laboratory and imaging methods support it congenital pneumonia at 34 weeks and above is frequently included among the diagnoses presenting with respiratory distress In addition RDS can also be seen rarely in this period 3
When we perform AUS imaging in the delivery room ie within the first 30 minutes we may see pulmonary edema diffuse B lines or a normal lung that has completed its transition and has more A lines Newborns who do not require neonatal hospitalization due to respiratory distress will also be followed up in the maternal ward and their clinic will be evaluated according to the AUS score they received in the delivery room
In the study both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed in the intensive care unit for inpatients and in the maternity ward for maternal patients at postnatal 2nd 6th and 24th hours The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants The secondary aim was to investigate the value of the course of AUS scores at postnatal 2 6 and 24 hours in predicting the respiratory prognosis of the newborn infant
Sources
1 Raimondi F Cattarossi L Copetti R Point-of-care chest ultrasound in the neonatal intensive care unit an Italian Perspective Neoreviews 201415e2-6
2 Escourrou G De Luca D Lung ultrasound decreased radiation exposure in preterm infants in a neonatal intensive care unit Acta Pediatrica 2016 e237-e239
3 Raimondi F et al A Multicenter Lung Ultrasound Study on Transient Tachypnea of the Neonate Neonatology 2019 115263-268
4 Oktem A Yigit S Oğuz B Celik T Haliloğlu M Yurdakok M Accuracy of Lung Ultrasonography in the Diagnosis of Respiratory Distress Syndrome in Newborns J Matern Fetal Neonatal Med 2019 Apr 221-6
5 Tandircioglu UA Yigit S Oguz B Kayki G Celik HT Yurdakok M Lung ultrasonography decreases radiation exposure in newborns with respiratory distress a retrospective cohort study Eur J Pediatr 2022 Mar18131029-1035 doi 101007s00431-021-04296-5
6 Liu J The Lung Ultrasound Score Cannot Accurately Evaluate the Severity of Neonatal Lung Disease J Ultrasound Med 2020 May3951015-1020 doi 101002jum15176 Epub 2019 Nov 18 PMID 31737918
7 Pang H Zhang B Shi J Zang J Qiu L Diagnostic value of lung ultrasound in evaluating the severity of neonatal respiratory distress syndrome Eur J Radiol 2019 Jul116186-191 doi 101016jejrad201905004
8 Brat R Yousef N Klifa R Reynaud S Shankar Aguilera S De Luca D Lung ultrasonography score to evaluate oxygenation and surfactant need in neonates treated with continuous positive airway pressure JAMA Pediatr 20151698e151797
9 Raimondi F Migliaro F Corsini I et al Lung Ultrasound Score Progress in Neonatal Respiratory Distress Syndrome Pediatrics 20211474e2020030528
10 Hillman NH Kallapur SG Jobe AH Physiology of transition from intrauterine to extrauterine life Clin Perinatol 2012394769-83
11 Poerio A Galletti S Baldazzi M Martini S Rollo A Spinedi S et al Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section Eur J Pediatr 2021 Mar1803869-876 doi 101007s00431-020-03789-z
Lung ultrasonography is widely used especially in conditions that mainly cause respiratory distress such as respiratory distress syndrome RDS pneumonia neonatal transient tachypnea NTRT congenital pneumonia meconium aspiration syndrome and pneumothorax 1 2 The reliability and specificity of AUS imaging especially in the diagnosis of RDS have been proven in many studies 123 The diagnosis of RDS on lung ultrasonography is made by visualization of the transition zone double lung point 3 In addition white lung appearance in RDS absence of pleural motion and barcode appearance in M mode in the presence of pneumothorax one of the air leakage syndromes and hepatizationconsolidation appearance in pneumonia are among ultrasonographic findings 13
In infants whose lung ultrasound findings are compatible with RDS and who clinically require surfactant surfactant therapy is given in a shorter time without waiting for chest radiography In a study involving 40 patients diagnosed with RDS it was found that there was a significant improvement ultrasonographically in the 4th hour of surfactant treatment and in another study it was shown that chest radiography was dramatically reduced with the use of AUS 4 5 In the light of this information we see that the use of AUS is becoming increasingly widespread in newborns AUS imaging has now become an objective value by scoring With these scores the relationship between the diagnosis of the disease and the score has been tried to be determined and related studies have been conducted 67 Images will be obtained using the linear probe of the device to be used for lung ultrasound and transferred to a cell phone The AUS scoring described in the studies of Brat et al and Raimondi et al 89 Accordingly both lungs will be evaluated as three areas on the right and left anterior superior anterior inferior and lateral and scored separately Anteriorly the region between the anterior axillary line and the parasternal line is divided into two by the line passing through the nipple Above is considered as the upper anterior region and below as the lower anterior region The area in the middle of the anterior and posterior axillary line is evaluated as the lateral region Each area is scored from 0 to 3 points If A lines are present 0 points are given if there are more than 3 B lines in an area 1 point is given if B lines are very dense and there are no A lines it is considered as white lung and 2 points are given If there is a consolidation image on AUS 3 points were given The maximum total score was 18 89 Figure 1
The transition from fetal to extrauterine life requires numerous rapid organ adaptations Clearance of fetal lung fluid surfactant secretion and the onset of steady breathing occur during pulmonary adaptation and changes in blood flow increased cardiac output and pulmonary vasodilation occur for the cardiovascular transition 10 This period typically lasts for two hours During this period placental breathing is replaced by spontaneous breathing When there is a delay in transition during this adaptation process tachypnea and moaning may be observed This process should be distinguished from transient tachypnea wet lung of the newborn In case of respiratory distress that persists after the first two hours postnatally the transition delay is avoided 10 Transient tachypnea of the newborn is considered as a possible diagnosis If there is a risk factor or respiratory distress persists and laboratory and imaging methods support it congenital pneumonia at 34 weeks and above is frequently included among the diagnoses presenting with respiratory distress In addition RDS can also be seen rarely in this period 3
When we perform AUS imaging in the delivery room ie within the first 30 minutes we may see pulmonary edema diffuse B lines or a normal lung that has completed its transition and has more A lines Newborns who do not require neonatal hospitalization due to respiratory distress will also be followed up in the maternal ward and their clinic will be evaluated according to the AUS score they received in the delivery room
In the study both AUS imaging and scoring will be performed in the delivery room within the first 30 minutes and AUS score evaluation will be performed in the intensive care unit for inpatients and in the maternity ward for maternal patients at postnatal 2nd 6th and 24th hours The hypothesis of this study is that newborns with high AUS scores will have high rates of respiratory morbidities and respiratory support in the neonatal unit The primary aim of the study was to determine the role and importance of AUS scores measured in the delivery room in predicting respiratory morbidities of infants The secondary aim was to investigate the value of the course of AUS scores at postnatal 2 6 and 24 hours in predicting the respiratory prognosis of the newborn infant
Sources
1 Raimondi F Cattarossi L Copetti R Point-of-care chest ultrasound in the neonatal intensive care unit an Italian Perspective Neoreviews 201415e2-6
2 Escourrou G De Luca D Lung ultrasound decreased radiation exposure in preterm infants in a neonatal intensive care unit Acta Pediatrica 2016 e237-e239
3 Raimondi F et al A Multicenter Lung Ultrasound Study on Transient Tachypnea of the Neonate Neonatology 2019 115263-268
4 Oktem A Yigit S Oğuz B Celik T Haliloğlu M Yurdakok M Accuracy of Lung Ultrasonography in the Diagnosis of Respiratory Distress Syndrome in Newborns J Matern Fetal Neonatal Med 2019 Apr 221-6
5 Tandircioglu UA Yigit S Oguz B Kayki G Celik HT Yurdakok M Lung ultrasonography decreases radiation exposure in newborns with respiratory distress a retrospective cohort study Eur J Pediatr 2022 Mar18131029-1035 doi 101007s00431-021-04296-5
6 Liu J The Lung Ultrasound Score Cannot Accurately Evaluate the Severity of Neonatal Lung Disease J Ultrasound Med 2020 May3951015-1020 doi 101002jum15176 Epub 2019 Nov 18 PMID 31737918
7 Pang H Zhang B Shi J Zang J Qiu L Diagnostic value of lung ultrasound in evaluating the severity of neonatal respiratory distress syndrome Eur J Radiol 2019 Jul116186-191 doi 101016jejrad201905004
8 Brat R Yousef N Klifa R Reynaud S Shankar Aguilera S De Luca D Lung ultrasonography score to evaluate oxygenation and surfactant need in neonates treated with continuous positive airway pressure JAMA Pediatr 20151698e151797
9 Raimondi F Migliaro F Corsini I et al Lung Ultrasound Score Progress in Neonatal Respiratory Distress Syndrome Pediatrics 20211474e2020030528
10 Hillman NH Kallapur SG Jobe AH Physiology of transition from intrauterine to extrauterine life Clin Perinatol 2012394769-83
11 Poerio A Galletti S Baldazzi M Martini S Rollo A Spinedi S et al Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section Eur J Pediatr 2021 Mar1803869-876 doi 101007s00431-020-03789-z
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