Doppler Ultrasound Compared With Stethoscope to Assess Heart Rate (HR)

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04242654
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Resuscitation	Procedure: Handheld fetal doppler ultrasound	N/A

Detailed Description

Obtaining a baby's 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 baby's chest to obtain an accurate HR rapidly that can be seen by the entire team. Before the ECG leads are placed on the baby's chest, the Neonatal Resuscitation Program (NRP) guidelines suggest that medical team members listen to the baby's 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 baby's 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 baby's HR, particularly in high-risk babies. The primary objective will be the time that it takes to obtain a baby's HR by Doppler ultrasound as compared to listening to a baby's 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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 17, 2020
• Actual Primary Completion Date: Oct 13, 2021
• Actual Study Completion Date: Oct 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doppler ultrasound Placement of Doppler US on chest to obtain newborn's heart rate.	Procedure: Handheld fetal doppler ultrasound; Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.
No Intervention: Stethoscope Placement of stethoscope on chest to obtain newborn's heart rate.

Outcome Measures

Primary Outcome Measures

1. Time to obtain HR (in seconds) [Up to approximately 1 minute]

   The primary outcome will be the time to obtain heart rate (HR), which will be defined as the time from when the neonate is placed on the radiant warmer to the time the HR is indicated to the entire resuscitation team.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Hours to 1 Hour
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All neonates admitted to the transitional nursery for resuscitation after delivery

Exclusion Criteria:

• Neonates with congenital heart disease, congenital diaphragmatic hernia

• Neonates whose mothers present and will have imminent delivery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Tina Leone A. Leone, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT04242654
• Other Study ID Numbers: AAAS5205
• First Posted: Jan 27, 2020
• Last Update Posted: Jan 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Columbia University: Doppler ultrasound; heart rate; neonatal resuscitation

Study Results

No Results Posted as of Jan 10, 2022