NCT04242654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2021

Completed
Last Updated

January 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

January 23, 2020

Last Update Submit

January 5, 2022

Conditions

Neonatal Resuscitation

Keywords

Doppler ultrasoundheart rateneonatal resuscitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Doppler ultrasound

EXPERIMENTAL

Placement of Doppler US on chest to obtain newborn's heart rate.

Procedure: Handheld fetal doppler ultrasound

Stethoscope

NO INTERVENTION

Placement of stethoscope on chest to obtain newborn's heart rate.

Interventions

Handheld fetal doppler ultrasoundPROCEDURE

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

Doppler ultrasound

Eligibility Criteria

Age0 Hours - 1 Hour
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All neonates admitted to the transitional nursery for resuscitation after delivery

You may not qualify if:

  • Neonates with congenital heart disease, congenital diaphragmatic hernia
  • Neonates whose mothers present and will have imminent delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Tina Leone A. Leone, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

August 17, 2020

Primary Completion

October 13, 2021

Study Completion

October 13, 2021

Last Updated

January 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)