Telemedicine for neonatal resuscitation in community hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial evaluates the effectiveness of real-time audio-video telemedicine consults with neonatologists, known as teleneonatology, on improving health outcomes for at-risk neonates delivered in community hospitals. The study employs a stepped wedge cluster randomized design to assess the impact on early mortality and morbidity rates, as well as the quality of delivery room care. By integrating telemedicine into neonatal resuscitation practices, the trial aims to enhance the support available to clinicians in community settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Providence Alaska Medical Center
  Anchorage, Alaska, United States Recruiting
• Bartlett Regional Hospital
  Juneau, Alaska, United States Recruiting
• PeaceHealth Ketchikan Medical Center
  Ketchikan, Alaska, United States Recruiting
• Chickasaw Nation Medical Center
  Ada, Oklahoma, United States Recruiting
• Jackson County Memorial Hospital
  Altus, Oklahoma, United States Recruiting
• Great Plains Regional Medical Center
  Elk City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Jennifer Fang, MD — Mayo Clinic
• Study coordinator: Jennifer Fang, MD, MS
• Email: fang.jennifer@mayo.edu
• Phone: 5072669397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.