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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04242654
Enrollment
32
Registered
2020-01-27
Start date
2020-08-17
Completion date
2021-10-13
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Resuscitation

Keywords

Doppler ultrasound, heart rate, neonatal resuscitation

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.

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.

Interventions

PROCEDUREHandheld fetal doppler ultrasound

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

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Hours to 1 Hours
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

Design outcomes

Primary

MeasureTime frameDescription
Time to obtain HR (in seconds)Up to approximately 1 minuteThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026