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

Mayo Clinic

Status: Enrolling

Conditions: Morbidity;Newborn; Death; Neonatal

Treatments: Other: Teleneonatology

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06087224

23-005502

R01HD112327 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 947 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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947 participants in 2 patient groups

Teleneonatology group

Experimental group

Description:

Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).

Treatment:

Other: Teleneonatology

Control group

No Intervention group

Description:

Study eligible neonates cared for by the community hospital team per the site's usual practice of care.