RecruitingNot Applicable

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

United States947 participantsStarted 2024-03-05

Plain-language 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.

Who can participate

Age range0 Days

SexALL

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Inclusion 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.
✓. 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

✕. 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.

What they're measuring

7-day mortality rate

Timeframe: 7 days

Trial details

NCT IDNCT06087224

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-07

Contact for this trial

Jennifer Fang, MD, MS

5072669397 fang.jennifer@mayo.edu

View on ClinicalTrials.gov More Death; Neonatal trials