An interventional study of Telemedicine consult in Neonatal Encephalopathy, sponsored by MaineHealth. Completed at 1 site in United States. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by MaineHealth · Not applicable, Interventional, and Diagnostic
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.
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 115 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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.
Babies that received telemedicine consult intervention.
Diagnostic Test: Telemedicine consult
Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
Time to Initiation of Therapeutic Hypothermia
Time to initiation of therapeutic hypothermia
Time frame: First 6 hours of life
| Milestone | Telemedicine |
|---|---|
| Started | 115 |
| Completed | 115 |
| Not completed | 0 |
Time to initiation of therapeutic hypothermia
| hours | Telemedicine |
|---|---|
| Time to Initiation of Therapeutic Hypothermia | 4.5 (3.5 to 5.0) |
Collected over Duration of the telemedicine consultation (10-30 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telemedicine | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) |
| Age, Customized(Participants) | Telemedicine |
|---|---|
| 0-6 hours | 115 |
| Sex: Female, Male(Participants) | Telemedicine |
|---|---|
| Female | 44 |
| Male | 71 |
| Ethnicity (NIH/OMB)(Participants) | Telemedicine |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 101 |
| Unknown or Not Reported | 13 |
| Race (NIH/OMB)(Participants) | Telemedicine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 97 |
| More than one race | 2 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | Telemedicine |
|---|---|
| United States | 115 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2023, 68 months.
Results were first posted in Sep 2025, 1 year 8 months after primary completion.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 68 months is above that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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