Neonatal Encephalopathy
Conditions
Keywords
Hypothermia, Induced, Telemedicine, Hospitals, Community
Brief summary
This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult (Maine NET), on the time to initiation of therapeutic hypothermia (TH) for 35 infants born in community hospitals in Maine compared with matched historical controls. Community hospital providers and tertiary care center provider satisfaction with the Maine NET platform will also be assessed. The hypothesis is that immediately available expert assessment via a teleconsult platform will promote earlier implementation of TH and be associated with high levels of provider satisfaction.
Detailed description
The study will recruit a total of 125 infants from the participating centers and anticipate that 35 of these subjects will be treated with therapeutic hypothermia and be utilized for the comparative analysis to historical controls. Not all infants recruited and provided a Maine NET consultation will be treated with TH and to have an adequate sample size to make statistical comparisons with historical controls we need to enroll more than 35 participants to ensure 35 have been treated with TH for the comparative analysis. In a secondary qualitative study, clinicians who completed Maine NET consults through the above clinical trial were interviewed about their experience with the consult. This secondary study will recruit up to 20 clinicians who completed a consult in this clinical trial.
Interventions
DIAGNOSTIC_TESTTelemedicine consult
Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
Sponsors
MaineHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No
Inclusion criteria
Infants included in this study will be born at a community hospital, will be in either high or moderate risk, will be younger than 6 hours of age at the time of the consultation and the decision will have been made to treat with TH. High risk infants will be defined as an umbilical cord pH of less than or equal to 7.0 or 5 minute APGAR score of less than or equal to 5 or a need for resuscitation (including respiratory support or chest compressions) or an abnormal exam (which may include flaccid tone, poor suck reflex or poor response to stimulation) or seizures at less than 6 hours of life. Moderate risk infants will be defined as an umbilical cord pH of less than or equal to 7.2 but greater than 7.0 or 5 minute APGAR score of less than 7 but greater than 5 or a perinatal event (such as placental abruption, uterine rupture, cord prolapse, or fetal-maternal hemorrhage) or an abnormal exam (which may include a hyper-alert state).
Exclusion criteria
Infants older than 6 hours at the time Maine NET is requested and infants for whom TH is not an appropriate therapy (e.g. due to premature birth or moribund status) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initiation of Therapeutic Hypothermia | First 6 hours of life | Time to initiation of therapeutic hypothermia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telemedicine Babies that received telemedicine consult intervention.
Telemedicine consult: Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy. | 115 |
| Total | 115 |
Baseline characteristics
| Characteristic | Telemedicine |
|---|---|
| Age, Customized 0-6 hours | 115 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 97 Participants |
| Region of Enrollment United States | 115 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 113 |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
Time to Initiation of Therapeutic Hypothermia
Time to initiation of therapeutic hypothermia
Time frame: First 6 hours of life
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telemedicine | Time to Initiation of Therapeutic Hypothermia | 4.5 hours |