Teleneonatology for Newborn Illness

Recruiting at 35 trial locations

Overseen By Bart M Demaerschalk, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Birth outside hospital, Severe anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: First 7 days of life

947 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Teleneonatology for newborn illness?

Research suggests that teleneonatology, which involves remote consultations by neonatologists, can improve the quality of care for high-risk newborns in community hospitals. Studies indicate that it may enhance newborn resuscitation and improve stability scores, which predict the risk of mortality for transported neonates. ^{1 2 3 4 5}

Is teleneonatology safe for newborns?

The available research does not specifically address the safety of teleneonatology, but it is used to manage critically ill newborns and improve care quality, suggesting it is generally considered safe in practice. ^{1 2 4 5 6}

How is the treatment Teleneonatology different from other treatments for newborn illness?

Teleneonatology is unique because it uses telemedicine to provide remote care and expert consultation for newborns, especially in community hospitals, which can improve the quality of care and outcomes for high-risk newborns. This approach allows specialists to assist local care teams in real-time, which is not typically possible with traditional in-person treatments. ^{1 2 4 6 7}

Research Team

Jennifer Fang, MD

Principal Investigator

Mayo Clinic

Bart Demaerschalk, MD

Principal Investigator

Mayo Clinic

Meegan G Van Straaten, MSPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

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

This group consists of outborn neonates at risk for complications.

You are a physician who attends baby resuscitations at an authorized local hospital location.

Exclusion Criteria

I needed intensive care or surgery within the first two weeks of my life due to a severe birth defect.

Birth outside of the hospital birthing center.

I have completed a fellowship in neonatal-perinatal medicine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Real-time audio-video telemedicine consults with a neonatologist for at-risk neonates in community hospitals

First 7 days of life

Continuous monitoring via telemedicine

Follow-up

Participants are monitored for early mortality and morbidity outcomes

7 days

Treatment Details

Interventions

• Teleneonatology

Trial Overview 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.

Participant Groups

Group I: Teleneonatology group Experimental Treatment 1 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 group Active Control 1 Intervention

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

Teleneonatology is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Teleneonatology for:

• Advanced neonatal resuscitations
• High-risk neonatal care

Approved in Canada as Neonatal Telemedicine for:

• Neonatal intensive care
• Remote neonatal consultations

Approved in European Union as Teleneonatology for:

• Neonatal emergency care
• Telemedicine for newborns

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Teleneonatology is advancing rapidly, offering innovative telemedicine solutions for various aspects of neonatal care, which can improve access to specialized medical services for newborns.

The chapter provides a comprehensive framework for developing, implementing, and evaluating teleneonatology programs, while also addressing barriers to implementation and suggesting potential solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and implementation of a teleneonatology program: Opportunities and challenges. Jagarapu, J., Savani, RC.[2021]

The pilot study demonstrated that a multicenter teleneonatology trial is feasible, achieving a high mean composite feasibility score of 4.6 out of 5 across 20 months, indicating strong site retention and timely data management.

With a very low eligibility error rate of 0.2% and 90% of screening logs completed on time, the pilot suggests that teleneonatology could effectively support at-risk neonates in community hospitals, paving the way for a larger clinical effectiveness trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. Fang, JL., Umoren, RA., Whyte, H., et al.[2023]

A survey of 111 participants from 6 community hospitals showed that 94.6% agreed that teleneonatology is necessary, and 96.2% found teleneonatology consults helpful, indicating strong support for this service among local care providers.

Barriers and facilitators to implementing teleneonatology were identified, including the importance of education, communication, and streamlined workflows, which are crucial for successful integration into community healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Study on the Barriers and Facilitators of Telemedicine for Newborn Resuscitation. Fang, JL., Asiedu, GB., Harris, AM., et al.[2022]

A study involving 92 newborns (47 receiving teleneonatology consults and 45 controls) found that teleneonatology significantly improved the quality of resuscitations, with a median quality rating of 7 compared to 4 for controls (P = 0.002).

Teleneonatology also led to better adherence to important medical processes, such as measuring temperature and blood gases, especially when the consult occurred within one hour of birth, indicating a greater benefit for preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of telemedicine on the quality of newborn resuscitation: A retrospective study. Fang, JL., Campbell, MS., Weaver, AL., et al.[2022]

In a study of 385 neonates transported from community hospitals, 42% received teleneonatology (TN) consults, but TN did not result in lower (better) California Transport Risk Index of Physiologic Stability (Ca-TRIPS) scores upon arrival of the transport team.

Although neonates who received TN had more severe conditions at baseline, the differences in Ca-TRIPS scores between those who received TN and those who did not were not significant after adjusting for these baseline characteristics, indicating the need for further randomized studies to assess TN's impact on neonatal stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of teleneonatology on the Transport Risk Index of Physiologic Stability score for outborn neonates: A prospective, observational study. Patel, RK., Kreofsky, BL., Hentz, RC., et al.[2023]

Providers from both tertiary NICUs and community hospitals overwhelmingly view teleneonatology as acceptable, appropriate, and feasible, with agreement rates between 88.6% and 99.0% across various statements.

The positive perceptions of teleneonatology were consistent regardless of the provider's professional role or experience, indicating strong support for using telemedicine in neonatal care, especially in rural areas with limited access to specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. Fang, JL., Umoren, R., Whyte, H., et al.[2023]

Telehealth in neonatology has significantly improved access to specialized care for neonates, particularly in rural settings, by enabling remote consultations and services like tele-echocardiography and neonatal resuscitation, which enhance patient outcomes.

The COVID-19 pandemic has accelerated the adoption of telehealth, leading to better parental education and smoother transitions from NICU to home, while also reducing healthcare costs for neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in neonatal medicine and resuscitation. Lapcharoensap, W., Lund, K., Huynh, T.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and implementation of a teleneonatology program: Opportunities and challenges. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Study on the Barriers and Facilitators of Telemedicine for Newborn Resuscitation. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

The impact of telemedicine on the quality of newborn resuscitation: A retrospective study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The impact of teleneonatology on the Transport Risk Index of Physiologic Stability score for outborn neonates: A prospective, observational study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in neonatal medicine and resuscitation. [2023]