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

Launched by MAYO CLINIC · Oct 12, 2023

Keywords

ClinConnect Summary

The TELENEO Trial is a study looking at how using telemedicine—specifically, video calls with a specialist in newborn care, called a neonatologist—can help improve the health of newborns who need special care right after birth in community hospitals. The goal is to see if having an expert available in real-time can make a difference for babies at risk of complications, such as those born too early or those needing advanced medical help right after delivery.

To be part of this trial, community hospital staff who help with newborn resuscitation can participate, as well as newborns who meet certain criteria. Eligible babies include those born before 32 weeks of pregnancy or those needing special procedures like breathing support shortly after birth. If a baby is born in a hospital and requires immediate medical attention, they might be considered for the study. However, some babies, like those with severe birth defects or those receiving comfort care instead of resuscitation, won't be included. Participants can expect to contribute to important research that could improve care for vulnerable newborns in the future.

Gender

ALL

Eligibility criteria

• 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.