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Behavioural Intervention

Teleneonatology for Newborn Illness

Q: Is recruitment underway for the clinical trial participants?

<p>Contrary to what is reported on clinicaltrials.gov, this particular medical trial has ceased recruitment of participants after the last update which was made October 12th 2023. Despite not actively participating in patient enrollment anymore, there are other 19 trials currently accepting enrollees.</p>

Q: How many venues are managing this clinical experiment?

<p>This study is being administered at Mayo Clinic <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a> in Rochester, Minnesota, the University of <a href="https://www.withpower.com/clinical-trials/oklahoma">Oklahoma</a> Health Sciences Center in Oklahoma City, Oklahoma and Seattle Children's Hospital located in Seattle <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>. Additionally there are 6 other trial locations.</p>

N/A

Recruiting

Led By Jennifer Fang, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV;

- positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study Summary

This trial will assess if telemedicine consults can improve health outcomes for high-risk newborns in community hospitals.

Who is the study for?

The TELENEO Trial is for newborns needing advanced resuscitation in community hospitals and the physicians attending these births. Eligible babies may have received ventilation or chest compressions, or be born preterm (<32 weeks). Physicians with neonatal-perinatal specialty are excluded, as are babies planned for comfort care, born outside a birthing center, or with severe congenital anomalies.Check my eligibility

What is being tested?

This study tests teleneonatology—real-time video calls with neonatologists during critical newborn resuscitations. It aims to improve early health outcomes of at-risk neonates by providing expert guidance to doctors in community hospitals when they face complex cases.See study design

What are the potential side effects?

Since this trial involves telemedicine consultation rather than direct medical treatment, traditional side effects related to medication or surgical interventions do not apply. However, technical issues could potentially delay care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an alternative airway in place for positive pressure ventilation.

Select...

I needed a machine to help me breathe immediately after birth for at least 10 minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

7-day mortality rate

Secondary outcome measures

Composite outcome of early mortality and morbidity

Early neonatal morbidity within the first 7 days

Highest level of resuscitation received in the delivery room

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Teleneonatology groupExperimental Treatment1 Intervention

Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).

Group II: Control groupActive Control1 Intervention

Study eligible neonates cared for by the community hospital team per the site's usual practice of care.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,766,541 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,671,850 Total Patients Enrolled

Jennifer Fang, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment underway for the clinical trial participants?

"Contrary to what is reported on clinicaltrials.gov, this particular medical trial has ceased recruitment of participants after the last update which was made October 12th 2023. Despite not actively participating in patient enrollment anymore, there are other 19 trials currently accepting enrollees."

Answered by AI

How many venues are managing this clinical experiment?

"This study is being administered at Mayo Clinic Minnesota in Rochester, Minnesota, the University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma and Seattle Children's Hospital located in Seattle Washington. Additionally there are 6 other trial locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer L. Fang 2024. "The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087224.

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