NCT04242654

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 0 Hours – 1 Hour
• Healthy volunteers: Accepted

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 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.

Conditions

• Neonatal Resuscitation

Interventions

Type	Name	Description
PROCEDURE	Handheld fetal doppler ultrasound	Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2020-01-27
• Last updated: 2022-01-10

Locations

1 site across 1 country: United States