NCT06087224 The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
| NCT ID | NCT06087224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Death; Neonatal |
| Study Type | INTERVENTIONAL |
| Enrollment | 947 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2029-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 947 participants in total. It began in 2024-03-05 with a primary completion date of 2029-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jennifer Fang, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06087224 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, studying Death; Neonatal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06087224 currently recruiting?
Yes, NCT06087224 is actively recruiting participants. Contact the research team at fang.jennifer@mayo.edu for enrollment information.
Where is the NCT06087224 trial being conducted?
This trial is being conducted at Anchorage, United States, Juneau, United States, Ketchikan, United States, Pheonix, United States and 11 additional locations.
Who is sponsoring the NCT06087224 clinical trial?
NCT06087224 is sponsored by Mayo Clinic. The principal investigator is Jennifer Fang, MD at Mayo Clinic. The trial plans to enroll 947 participants.