N/A N=115 Diagnostic

Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

Neonatal Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT03706417 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Time to Initiation of Therapeutic Hypothermia — 4.5 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Telemedicine consult (Diagnostic_test)
Age: Pediatric
Sex: All
Sponsor: MaineHealth
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Initiation of Therapeutic Hypothermia	4.5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03706417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.