An interventional study of Handheld fetal doppler ultrasound in Neonatal Resuscitation, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 0 Hours to 1 Hour, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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.
Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Placement of Doppler US on chest to obtain newborn's heart rate.
Procedure: Handheld fetal doppler ultrasound
Placement of stethoscope on chest to obtain newborn's heart rate.
Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.
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.
Time frame: Up to approximately 1 minute
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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