Death; Neonatal, Morbidity;Newborn
Conditions
Keywords
Telemedicine, Newborn, Resuscitation
Brief 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.
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.
Interventions
OTHERTeleneonatology
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
No
Inclusion criteria
GROUP 1: Community hospital clinicians To be eligible to participate in this study, an individual must meet all of the following criteria: 1. A clinician who attends newborn resuscitations at a participating community hospital spoke site. 2. 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 1. Preterm birth at less than 32 weeks' gestation at delivery; OR 2. Need for advanced resuscitation defined as: 1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR 2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR 3. chest compressions.
Exclusion criteria
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: 1. Birth outside of the hospital birthing center. 2. Neonatal transport team present at time of birth and providing resuscitative care. 3. Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life. 4. Plan for comfort care (non-resuscitation) following delivery. 5. In-person neonatology-trained physician present for the resuscitation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day mortality rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early neonatal morbidity within the first 7 days | 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 |
| Composite outcome of early mortality and morbidity | 7 days | 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. |
| Highest level of resuscitation received in the delivery room | First hour of life | 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. |
Countries
Canada, United States
Contacts
Primary ContactJennifer Fang, MD, MS
Backup ContactBart M Demaerschalk, MD, MSc
Outcome results
None listed