Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

NCT03706417 | Completed Results

• 1 other identifier: MMP PEDIATRIC NEURO [11000028]
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Encephalopathy

Keywords

Hypothermia, Induced; Telemedicine; Hospitals, Community

Outcome Measures

Primary Outcomes (1)

• Time to Initiation of Therapeutic Hypothermia

  Time to initiation of therapeutic hypothermia

  First 6 hours of life

Study Arms (1)

Telemedicine

EXPERIMENTAL

Babies that received telemedicine consult intervention.

Diagnostic Test: Telemedicine consult

Interventions

Telemedicine consult DIAGNOSTIC_TEST

Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.

Telemedicine

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: MaineHealth

alexa.craig@mainehealth.org

207-396-6920

Study Officials

• Alexa Craig, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: April 30, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)