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New treatment option for Death; Neonatal
Official title The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
ClinicalTrials.gov ID: NCT06087224
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 and older
You may be able to join if
- GROUP 1: Community hospital clinicians To be eligible to participate in this study, an individual must meet all of the following 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. GROUP 2: At-risk outborn neonates To be eligible...
- Need for advanced resuscitation defined as:
- positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
You likely can't join if
- GROUP 1: Community hospital clinicians None GROUP 2: At-risk outborn neonates A neonate born in a participating community hospital spoke site who...
- 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.
See the full eligibility criteria
- GROUP 1: Community hospital clinicians To be eligible to participate in this study, an individual must meet all of the following 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. GROUP 2: At-risk outborn neonates To be eligible for this study, a neonate born in a participating community hospital...
- 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.
- 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:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Juneau, Alaska, United States
- Ketchikan, Alaska, United States
- Pheonix, Arizona, United States
- Rochester, Minnesota, United States
- Ada, Oklahoma, United States
- Altus, Oklahoma, United States
- Elk City, Oklahoma, United States
- Oklahoma City, Oklahoma, United States
- Anacortes, Washington, United States
- Everett, Washington, United States
- Port Angeles, Washington, United States
- Seattle, Washington, United States
- Wenatchee, Washington, United States
- Columbus, Wisconsin, United States
- Fort Atkinson, Wisconsin, United States
- Madison, Wisconsin, United States
- Prairie du Sac, Wisconsin, United States
- Reedsburg, Wisconsin, United States
- Watertown, Wisconsin, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Juneau, Alaska, United States; Ketchikan, Alaska, United States; Pheonix, Arizona, United States; Rochester, Minnesota, United States; Ada, Oklahoma, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.