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NCT Number: NCT06087224

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

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.

Recruiting

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Key information

Conditions

Death; Neonatal Death Female Urogenital Diseases and Pregnancy Complications Morbidity;Newborn Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stevenson Memorial Hospital, Alliston, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 site.
  • 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

  • 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 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:

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

Treatment and study plan

Teleneonatology

Other

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.

Primary outcomes

  1. 7-day mortality rate

    Time frame: 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 outcomes

  1. Early neonatal morbidity within the first 7 days

    Time frame: 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

  2. Composite outcome of early mortality and morbidity

    Time frame: 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.

  3. Highest level of resuscitation received in the delivery room

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bart M Demaerschalk, MD, MSc

CONTACT

[email protected]

4803018000

Jennifer Fang, MD, MS

CONTACT

[email protected]

5072669397

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 17, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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