Skip to main content
Clinical Trials/NCT04242654
NCT04242654
Completed
Not Applicable

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

Columbia University1 site in 1 country32 target enrollmentAugust 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Resuscitation
Sponsor
Columbia University
Enrollment
32
Locations
1
Primary Endpoint
Time to obtain HR (in seconds)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2020
End Date
October 13, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to obtain HR (in seconds)

Time Frame: Up to approximately 1 minute

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.

Study Sites (1)

Loading locations...

Similar Trials