The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Co… (NCT06087224) | Clinical Trial Compass
RecruitingNot Applicable
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
United States, Canada947 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 range
0 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.