Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925075
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-08
First Post:
2023-06-21
Brief Title:
Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress
Sponsor:
Phoenix Childrens Hospital
Organization:
Phoenix Childrens Hospital
Study Overview
Official Title:
Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress A Multicenter Prospective Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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:
The goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems The main question this study aims to answer is Can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants
Detailed Description:
This is a multicenter study including preterm infants born less than 32 weeks gestational age and with a diagnosis of respiratory distress syndrome RDS Our primary aim is to determine the ability of lung ultrasounds performed in the first month of life to predict the development of bronchopulmonary dysplasia BPD at 36 weeks postmenstrual age
Secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus PDA at time of diagnosis as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course
Hypothesis
1 LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC08
2 Higher LUS scores would correlate with higher severity of hemodynamically significant PDA
3 LUS scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids
Secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus PDA at time of diagnosis as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course
Hypothesis
1 LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC08
2 Higher LUS scores would correlate with higher severity of hemodynamically significant PDA
3 LUS scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids
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