Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04242654
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2020-01-23
Brief Title:
Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate HR
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Randomized-Controlled Trial of Handheld Doppler Ultrasound Compared With Auscultation by Stethoscope to Assess Heart Rate During the Resuscitation of High-risk Neonates
Status:
COMPLETED
Status Verified Date:
2022-01
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:
This is a prospective randomized controlled trial comparing heart rate measurement by Doppler ultrasound or auscultation with a stethoscope in newborn infants who require stabilization or resuscitation immediately after birth Enrolled subjects will be randomly assigned to have their heart rate HR obtained by stethoscope ST or by Doppler ultrasound DO Neonates will be resuscitated in accordance with the Neonatal Resuscitation Program NRP guidelines
Detailed Description:
Obtaining a babys heart rate HR is an important part of neonatal resuscitation in the delivery room and helps the medical team decide how to treat the baby When babies do not breathe well on their own the medical team places electrocardiogram ECG leads on the babys chest to obtain an accurate HR rapidly that can be seen by the entire team Before the ECG leads are placed on the babys chest the Neonatal Resuscitation Program NRP guidelines suggest that medical team members listen to the babys HR using a stethoscope for 6 seconds However it can take longer than 6 seconds for medical team members to obtain a HR which can delay a babys care The purpose of this study is to determine if Doppler ultrasound is a useful alternative tool aside from a stethoscope that can be used to quickly obtain a babys HR particularly in high-risk babies The primary objective will be the time that it takes to obtain a babys HR by Doppler ultrasound as compared to listening to a babys HR with a stethoscope With this study the investigators will be able to understand if Doppler ultrasound is a useful tool in the resuscitation of babies who are high risk
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?:
False
Is an FDA AA801 Violation?:
None