Trial Outcomes & Findings for Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings (NCT NCT03706417)
NCT ID: NCT03706417
Last Updated: 2025-09-12
Results Overview
Time to initiation of therapeutic hypothermia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
First 6 hours of life
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
Telemedicine
Babies that received telemedicine consult intervention.
Telemedicine consult: Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings
Baseline characteristics by cohort
| Measure |
Telemedicine
n=115 Participants
Babies that received telemedicine consult intervention.
Telemedicine consult: Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
|
|---|---|
|
Age, Customized
0-6 hours
|
115 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: First 6 hours of lifeTime to initiation of therapeutic hypothermia
Outcome measures
| Measure |
Telemedicine
n=113 Participants
Babies that received telemedicine consult intervention.
Telemedicine consult: Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
|
|---|---|
|
Time to Initiation of Therapeutic Hypothermia
|
4.5 hours
Interval 3.5 to 5.0
|
Adverse Events
Telemedicine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place