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Recruiting
View on ClinicalTrials.gov

Testing Teleneonatology for death

Official title: The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Condition: Death; NeonatalSponsor: Mayo ClinicTarget enrollment: 947
  • 2 groups
  • Sites in Alliston, Brampton and 8 more cities
  • Recruiting
Stevenson Memorial Hospital, Alliston, OntarioWilliam Osler Health System - Brampton Civic Hospital, Brampton, OntarioMichael Garron Hospital, East York, OntarioWilliam Osler Health System - Etobicoke General Hospital, Etobicoke, OntarioTrillium Health Partners - Credit Valley Health, Mississauga, OntarioSouthlake Regional Health Centre, Newmarket, OntarioOrillia Soldiers Memorial Hospital, Orillia, OntarioScarborough Health Network - Centenary Hospital, Scarborough Village, OntarioScarborough Health Network - General Hospital, Scarborough Village, OntarioNorth York General Hospital, Toronto, OntarioSunnybrook Health Sciences Centre, Toronto, OntarioMount Sinai Hospital, Toronto, OntarioThe Hospital for Sick Children, Toronto, OntarioUnity Health - St. Joseph's Health Centre, Toronto, OntarioMackenzie Health - Cortellucci Vaughan Hospital, Vaughan, Ontario

Interventions

  • Other intervention

    Teleneonatology

    Real-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital.

Canadian Sites (15)

15 of 15 recruiting

  • Stevenson Memorial Hospital

    Alliston, Ontario

    Recruiting
  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario

    Recruiting
  • Michael Garron Hospital

    East York, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for18 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +GROUP 1: Community hospital clinicians
  • +To be eligible to participate in this study, an individual must meet all of the following criteria:
  • +A clinician who attends newborn resuscitations at a participating community hospital spoke siteTrial siteA hospital or clinic where a study is actually run.Read more →.
  • +Provision of informed oral consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to any mandatory study specific procedures and analyses.
  • +GROUP 2: At-risk outborn neonates To be eligible for this study, a neonate born in a participating community hospital spoke site must meet \*at least one\* of the following inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
  • +Preterm birth at less than 32 weeks' gestation at delivery; OR
  • +Need for advanced resuscitation defined as:
  • +positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
  • +placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR
  • +chest compressions.

Exclusion

  • GROUP 1: Community hospital clinicians None
  • GROUP 2: At-risk outborn neonates
  • A neonate born in a participating community hospital spoke siteTrial siteA hospital or clinic where a study is actually run.Read more → who meets any of the following criteria will be excluded from the study:
  • Birth outside of the hospital birthing center.
  • Neonatal transport team present at time of birth and providing resuscitative care.
  • Plan for comfort care (non-resuscitation) following delivery.
  • In-person neonatology-trained physician present for the resuscitation.
  • Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Teleneonatology.

Registry label: A: Teleneonatology group

Group B receives no study treatment and is followed for comparison.

Registry label: B: Control group

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 0 days, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 947 people.

The study is currently expected to finish around May 2029.

The main measurement is taken over: 7 days.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

7-day mortality rate — measured over 7 days.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06087224 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About TeleneonatologyOther

Real-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 0 days.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 0 days, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 7 days.

The study as a whole is currently expected to finish around 2029-05-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 947 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 16 locations, including: Alliston, Ontario, Canada; Brampton, Ontario, Canada; East York, Ontario, Canada; Etobicoke, Ontario, Canada; Mississauga, Ontario, Canada; Newmarket, Ontario, Canada, and 10 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.

Other Sites (7)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Island Health

Anacortes, Washington, United States

Providence Regional Medical Center Everett

Everett, Washington, United States

Olympic Medical Center

Port Angeles, Washington, United States

Seattle Children's Hospital

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.