Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04242654
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase N/A
Start date August 17, 2020
Completion date October 13, 2021

See also
  Status Clinical Trial Phase
Completed NCT04076189 - Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid N/A
Not yet recruiting NCT03660033 - ECG Monitoring During NRP: a False Sense of Security? N/A
Completed NCT03730025 - Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation N/A
Recruiting NCT04056091 - Back Rubs or Foot Flicks for Neonatal Stimulation at Birth in a Low-resource Setting N/A
Terminated NCT03885492 - The Baby-Saver Kit: Clinical Testing of a Device for Neonatal Resuscitation With Intact Cord in Uganda
Completed NCT01869582 - Safer Births - Reducing Perinatal Mortality N/A
Recruiting NCT06258187 - Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room N/A
Completed NCT03133663 - Heart Rate Evaluation and Resuscitation Trial in Preterm Neonates N/A
Completed NCT03799861 - Newborn Heart Rate as a Catalyst for Improved Survival
Completed NCT05472155 - SUCTIONING AT BIRTH WITH BULB SYRINGE OR SUCTION CATHETER: A RANDOMIZED CONTROLLED TRIAL N/A
Recruiting NCT01963936 - Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study Phase 3
Completed NCT03844009 - Computer Debriefing and Screen-based Simulation N/A
Completed NCT02840682 - Outcomes of Neonatal Resuscitation N/A
Withdrawn NCT02629887 - Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation N/A