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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized-Controlled Trial of Handheld Doppler Ultrasound Compared With Auscultation by Stethoscope to Assess Heart Rate During the Resuscitation of High-risk Neonates

Conditions
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Neonatal Resuscitation

Intervention / Treatment
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* Procedure: Handheld fetal doppler ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doppler ultrasound, heart rate, neonatal resuscitation