Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408480
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-25
Brief Title:
Neonatologist-performed Lung Ultrasound in the Delivery Room
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Neonatologist-performed Lung Ultrasound During Immediate Transition After Birth to Predict the Need for Respiratory Support Persisting More Than 1 Hour - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
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 objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound NPLUS during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth
Detailed Description:
Lung ultrasound is an emerging clinical tool to assess the lung in a dynamic way Recently the focus has been on establishing lung ultrasound in the neonatal intensive care unit NICU as a point-of care application
Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life Especially in the first hours after birth respiratory distress syndromes RDS may occur due to delayed lung fluid clearance after birth
While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition it remains difficult to identify neonates in need for further respiratory support at the NICU Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs
There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous
Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life Especially in the first hours after birth respiratory distress syndromes RDS may occur due to delayed lung fluid clearance after birth
While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition it remains difficult to identify neonates in need for further respiratory support at the NICU Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs
There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous
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