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

Columbia University

Status: Completed

Conditions: Neonatal Resuscitation

Treatments: Procedure: Handheld fetal doppler ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04242654

AAAS5205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: Under 1 hour old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Doppler ultrasound

Experimental group

Description:

Placement of Doppler US on chest to obtain newborn's heart rate.

Treatment:

Procedure: Handheld fetal doppler ultrasound

Stethoscope

No Intervention group

Description:

Placement of stethoscope on chest to obtain newborn's heart rate.