Death; NeonatalNCT06087224
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
A study testing Teleneonatology in people with Death; Neonatal and Morbidity;Newborn, run by Mayo Clinic at 36 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Death; Neonatal, Morbidity;Newborn
- What is being tested?
- Teleneonatology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 947 participants
- Where
- 36 sitesin 2 countries
- Study dates
- 5 Mar 2024to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 spoke site must meet at least one of the following inclusion criteria
- Preterm birth at less than 32 weeks' gestation at delivery; OR
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 2 countries
United States21 sites, 19 recruiting
- Recruiting
Chickasaw Nation Medical Center
Ada, Oklahoma, 74820
Jonathan Walther, MD, (580) 436-3980, Jonathan.Walther@Chickasaw.net
Bobby Saunkeah, bobby.saunkeah@chickasaw.net
- Recruiting
Jackson County Memorial Hospital
Altus, Oklahoma, 73521
Lindsey King, MD, 580-379-5000, LindseyKing@jcmh.com
Natalie Dabelstein, RN
- Recruiting
Island Health
Anacortes, Washington, 98221
Jason Hogge, MD, 360-299-1300, jhogge@islandhospital.org
Lauren Mireles, RN
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Teresa Lam, MD, 907-562-2211, teresa.lam@pediatrix.com
Mary-Alice Johnson, MD, Mary.Johnson@providence.org
- Recruiting
Prairie Ridge Health
Columbus, Wisconsin, 53925
Rachel Svendsen, RN, 920-623-1299, rsvendsen@prairieridge.health
Jamie Hendrix, RN
- Recruiting
Great Plains Regional Medical Center
Elk City, Oklahoma, 73648
Courtney Allen, BSN, 580-821-5326, callen@gprmc-ok.com
Stacy Ford, RN
- Recruiting
Providence Regional Medical Center Everett
Everett, Washington, 98201
Mihai Puia-Dumitrescu, MD, MPH, 207-838-9606, mihaipd@uw.edu
- Recruiting
Fort HealthCare
Fort Atkinson, Wisconsin, 53538
Deborah Schumacher, RN, 920-568-5000, deborah.schumacher@forthc.com
Catherine Sweeney, MD
- Recruiting
Bartlett Regional Hospital
Juneau, Alaska, 99801
Jessica Sperry, RN, 907-796-8657, jmsperry@bartletthospital.org
Amy Dressel, MD
- Recruiting
PeaceHealth Ketchikan Medical Center
Ketchikan, Alaska, 99901
Kristin Fahey, RN, 907-225-5171, KFahey@peacehealth.org
Christine Schubert, MEd
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53715
Cassie Nelson, 608-417-6236, cenelson4@wisc.edu
Jamie Limjoco, MD
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Erin Bohon, 405-271-5215, Erin-Bohon@ouhsc.edu
Samuel Levin, MD
- Active, not recruiting
Mayo Clinic Arizona
Pheonix, Arizona, 85054
- Recruiting
Olympic Medical Center
Port Angeles, Washington, 98362
Laura Bullen, MD, 360-477-9447, lbullen@olympicmedical.org
Christina Johnson, RN
- Recruiting
Sauk Prairie Healthcare
Prairie du Sac, Wisconsin, 53578
Todd Schad, MD, 608-643-3311, tschad@prairieclinic.com
Sarah Jorgenson
- Recruiting
Reedsburg Area Medical Center
Reedsburg, Wisconsin, 53959
Anne Harris, MD, 608-888-2696, aharris@ramchealth.org
Pam Dregney, RN
- Active, not recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
John Feltner, 206-987-2599, jfeltner@uw.edu
Mark Lo, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
John Feltner, 206-543-3200, jfeltner@uw.edu
Rachel Umoren, MD
- Recruiting
Watertown Regional Medical Center
Watertown, Wisconsin, 53098
Patricia Gedemer, RN, 920-261-4210, pgedeme@watertownregional.com
Megan Wierschke
- Recruiting
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
Brenda Baumeister, MD, 509-662-1511 ext. 33131, brenda.baumeister@confluencehealth.org
Tamaris Clark, RN
Canada15 sites, 15 recruiting
- Recruiting
Stevenson Memorial Hospital
Alliston, Ontario, L9R 1W7
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Ihab Khalil, MBBS
- Recruiting
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R 3J7
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Sangeet Kathuria, MBBS
- Recruiting
Michael Garron Hospital
East York, Ontario, M4C 3E7
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Sehr Ansari, MBBS
- Recruiting
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Sangeet Kathuria, MBBS
- Recruiting
Trillium Health Partners - Credit Valley Health
Mississauga, Ontario, L5M 2N1
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Maura Mansur
- Recruiting
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Madeline Drake, MB, BCh
- Recruiting
Orillia Soldiers Memorial Hospital
Orillia, Ontario, L3V 2Z3
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Ryan Smith, MD
- Recruiting
Scarborough Health Network - Centenary Hospital
Scarborough Village, Ontario, M1E 4B9
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Peter Azzopardi, MD
- Recruiting
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, M1P 2V5
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Peter Azzopardi, MD
- Recruiting
North York General Hospital
Toronto, Ontario, M2K 1E1
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Shaheen Doctor, MD
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Eugene Ng, MD
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Prakesh Shah, MBBS
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Brenda Graydon, brenda.graydon@sickkids.ca
- Recruiting
Unity Health - St. Joseph's Health Centre
Toronto, Ontario, M6R 1B5
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Rana Esmaeilizand, MD
- Recruiting
Mackenzie Health - Cortellucci Vaughan Hospital
Vaughan, Ontario, L6A 4Z3
Ashley Mehta, 1-416-813-7654, ashley.mehta@sickkids.ca
Maksim Kirtsman, MDCM
About this study
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.
Read the detailed description
This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.
- Conditions
- Death; Neonatal, Morbidity;Newborn
- Being tested
- Teleneonatology
- Keywords
- Telemedicine, Newborn, Resuscitation
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleneonatologyOther
Real-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital.
| Study group | Role | What they receive |
|---|---|---|
| Teleneonatology group | Experimental | Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU). Receives: Other: Teleneonatology |
| Control group | No intervention | Study eligible neonates cared for by the community hospital team per the site's usual practice of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day mortality rate
Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
Measured: 7 days
Secondary outcomes (3)
Early neonatal morbidity within the first 7 days
Percentage of neonates classified as having early neonatal morbidity, defined as diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging (grade 3 or 4 intraventricular hemorrhage per Papile classification or cerebellar hemorrhage), or seizures on electroencephalogram in the first seven days of life
Measured: 7 days
Composite outcome of early mortality and morbidity
Percentage of neonates classified as having early neonatal mortality or morbidity, defined as dying or diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life.
Measured: 7 days
Highest level of resuscitation received in the delivery room
The highest level of delivery room resuscitation during the first hour of life, on a scale of 1-6, corresponding to routine care; oxygen and/or continuous positive airway pressure (CPAP); positive pressure ventilation (PPV); advanced airway placement (endotracheal tube or laryngeal mask); chest compressions; or epinephrine administration, respectively.
Measured: First hour of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start5 Mar 2024
- Primary completion7 Feb 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Death; NeonatalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 947 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jennifer L. Fang, Mayo Clinic
- Investigators
- Jennifer Fang, MD, Principal investigator, Mayo ClinicBart M Demaerschalk, MD, Principal investigator, Mayo ClinicMeegan G Van Straaten, MSPH, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087224
- Sponsor's protocol ID
- 23-005502
- Other IDs
- R01HD112327
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang JL, Umoren R, Whyte H, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Colby CE, Herrin J, Jacobson RM, Demaerschalk BM. Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. Am J Perinatol. 2023 Oct;40(14):1521-1528. doi: 10.1055/a-1656-6363. Epub 2021 Sep 28.
PubMed 34583392Fang JL, Whyte H, Umoren R, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Herrin J, Demaerschalk BM. Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial. Telemed J E Health. 2022 Oct;28(10):1489-1495. doi: 10.1089/tmj.2021.0574. Epub 2022 Feb 15.
PubMed 35167373Fang JL, Umoren RA, Whyte H, Limjoco J, Makkar A, Behl S, Lo MD, White L, Culjat M, Taylor JS, Kathuria S, Webb MO, Schad T, Shafranski S, Yankanah R, Herrin J, Demaerschalk BM. Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. Pediatr Res. 2023 Oct;94(4):1555-1561. doi: 10.1038/s41390-023-02659-2. Epub 2023 May 19.
PubMed 37208433
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
- ClinicalTrials.gov ID
- NCT06087224
- Acronym / sponsor ID
- 23-005502
- Conditions
- Death; Neonatal, Morbidity;Newborn
- Keywords
- Telemedicine, Newborn, Resuscitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 947 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 7 Feb 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Teleneonatology group | Experimental | Other: TeleneonatologyStudy eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU). |
| Control group | No intervention | –Study eligible neonates cared for by the community hospital team per the site's usual practice of care. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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 spoke site must meet at least one of the following inclusion criteria
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleneonatologyReal-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital. | Other | Teleneonatology group |
Primary outcome
7-day mortality rate
Time frame: 7 days
Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
3 secondary outcomes
Early neonatal morbidity within the first 7 days
Time frame: 7 days
Composite outcome of early mortality and morbidity
Time frame: 7 days
Highest level of resuscitation received in the delivery room
Time frame: First hour of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 34583392Fang JL, Umoren R, Whyte H, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Colby CE, Herrin J, Jacobson RM, Demaerschalk BM. Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. Am J Perinatol. 2023 Oct;40(14):1521-1528. doi: 10.1055/a-1656-6363. Epub 2021 Sep 28.
- Background: PubMed 35167373Fang JL, Whyte H, Umoren R, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Herrin J, Demaerschalk BM. Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial. Telemed J E Health. 2022 Oct;28(10):1489-1495. doi: 10.1089/tmj.2021.0574. Epub 2022 Feb 15.
- Background: PubMed 37208433Fang JL, Umoren RA, Whyte H, Limjoco J, Makkar A, Behl S, Lo MD, White L, Culjat M, Taylor JS, Kathuria S, Webb MO, Schad T, Shafranski S, Yankanah R, Herrin J, Demaerschalk BM. Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. Pediatr Res. 2023 Oct;94(4):1555-1561. doi: 10.1038/s41390-023-02659-2. Epub 2023 May 19.
- Individual participant dataSharing planned: No
Related trials for Death; Neonatal
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Fang, MD principal investigator
Mayo Clinic
Bart M Demaerschalk, MD principal investigator
Mayo Clinic
Meegan G Van Straaten, MSPH study director
Mayo Clinic
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleneonatology in people with Death; Neonatal and Morbidity;Newborn, run by Mayo Clinic at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Fang, MD, MS (5072669397, fang.jennifer@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day mortality rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087224, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.