The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Not Applicable

Recruiting

• Conditions: Death; Neonatal; Morbidity;Newborn

• Registration Number: NCT06087224
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-17
• Study Start: 2024-03-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2029-02-07
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 947

Inclusion Criteria

GROUP 1: Community hospital clinicians

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. A clinician who attends newborn resuscitations at a participating community hospital spoke site.
2. Provision of informed oral consent 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 criteria

1. Preterm birth at less than 32 weeks' gestation at delivery; OR

2. Need for advanced resuscitation defined as:

   1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
   2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR
   3. chest compressions.

Exclusion Criteria

GROUP 1: Community hospital clinicians None

GROUP 2: At-risk outborn neonates

A neonate born in a participating community hospital spoke site who meets any of the following criteria will be excluded from the study:

1. Birth outside of the hospital birthing center.
2. Neonatal transport team present at time of birth and providing resuscitative care.
3. Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.
4. Plan for comfort care (non-resuscitation) following delivery.
5. In-person neonatology-trained physician present for the resuscitation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
7-day mortality rate	7 days	Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.

Secondary Outcome Measures

Name	Time	Method
Early neonatal morbidity within the first 7 days	7 days	Percentage of neonates classified as having early neonatal morbidity, defined as diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging (grade 3 or 4 intraventricular hemorrhage per Papile classification or cerebellar hemorrhage), or seizures on electroencephalogram in the first seven days of life
Highest level of resuscitation received in the delivery room	First hour of life	The highest level of delivery room resuscitation during the first hour of life, on a scale of 1-6, corresponding to routine care; oxygen and/or continuous positive airway pressure (CPAP); positive pressure ventilation (PPV); advanced airway placement (endotracheal tube or laryngeal mask); chest compressions; or epinephrine administration, respectively.
Composite outcome of early mortality and morbidity	7 days	Percentage of neonates classified as having early neonatal mortality or morbidity, defined as dying or diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life.

Trial Locations

Locations (34)

Stevenson Memorial Hospital; 🇨🇦 Alliston, Ontario, Canada

William Osler Health System - Brampton Civic Hospital; 🇨🇦 Brampton, Ontario, Canada

Michael Garron Hospital; 🇨🇦 East York, Ontario, Canada

William Osler Health System - Etobicoke General Hospital; 🇨🇦 Etobicoke, Ontario, Canada

Trillium Health Partners - Credit Valley Health; 🇨🇦 Mississauga, Ontario, Canada

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

Orillia Soldiers Memorial Hospital; 🇨🇦 Orillia, Ontario, Canada

Scarborough Health Network - Centenary Hospital; 🇨🇦 Scarborough, Ontario, Canada

Scarborough Health Network - General Hospital; 🇨🇦 Scarborough, Ontario, Canada

North York General Hospital; 🇨🇦 Toronto, Ontario, Canada

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