NCT04258722

Brief Summary

Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

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

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

2.2 years

First QC Date

February 4, 2020

Last Update Submit

December 15, 2023

Conditions

Newborn Morbidity

Keywords

telemedicinesimulationneonatal resuscitation

Outcome Measures

Primary Outcomes (1)

  • No flow fraction

    The proportion of time for which the mannequin received no effective compression (the number of seconds without effective chest compressions divided by the total number of seconds)

    From start time of compression until 60 seconds have elapsed

Secondary Outcomes (25)

  • Temperature regulation

    From baseline to 30 seconds

  • Time of first heart rate check (seconds)

    From baseline until heart rate check up to 5 minutes

  • Heart rate check compliance

    From baseline to 60 seconds up to 5 minutes

  • Time of bag mask ventilation (seconds)

    From baseline to bag mask placement up to 5 minutes

  • Bag mask ventilation compliance

    From baseline to 60 seconds

  • +20 more secondary outcomes

Study Arms (2)

Trainee + Teleneonatologist

EXPERIMENTAL

Trainee, teleneonatologist, nurse, and respiratory therapist will perform resuscitation

Other: Resuscitation Personnel

Trainee

ACTIVE COMPARATOR

Trainee, nurse, and respiratory therapist will perform resuscitation.

Other: Resuscitation Personnel

Interventions

Resuscitation PersonnelOTHER

Type of resuscitation team

TraineeTrainee + Teleneonatologist

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Study Officials

  • Samuel Gentle, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be masked to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

November 30, 2020

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)