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

Neonatal Resuscitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242654
• Other study ID #: AAAS5205
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: October 13, 2021

Study information

• Verified date: January 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Resuscitation

Intervention

Procedure:
• Handheld fetal doppler ultrasound
Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to obtain HR (in seconds)	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.	Up to approximately 1 minute