Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

Sponsor

MaineHealth (Other)

Overall Status

Recruiting

CT.gov ID

NCT03706417

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 10 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. We hypothesize that immediately available expert assessment via a teleconsult platform will promote earlier implementation of TH and be associated with high levels of provider satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Encephalopathy	Diagnostic Test: Telemedicine consult	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Leveraging Telemedicine to Reduce Disparities in Time to Initiation of Therapeutic Hypothermia in Rural Settings; a Pilot Feasibility Study

Actual Study Start Date :

Apr 30, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemedicine Babies that received telemedicine consult intervention.	Diagnostic Test: Telemedicine consult Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
No Intervention: Historical control Historical controls who have not received a telemedicine consult.

Arm

Intervention/Treatment

Experimental: Telemedicine

Babies that received telemedicine consult intervention.

Diagnostic Test: Telemedicine consult

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

No Intervention: Historical control

Historical controls who have not received a telemedicine consult.

Outcome Measures

Primary Outcome Measures

Time to initiation of therapeutic hypothermia [First 6 hours of life]
Time to initiation of therapeutic hypothermia

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04102

Sponsors and Collaborators

MaineHealth

Investigators

Principal Investigator: Alexa Craig, MD, MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexa Craig, Assistant Professor of Pediatrics, MaineHealth

ClinicalTrials.gov Identifier:

NCT03706417

Other Study ID Numbers:

MMP PEDIATRIC NEURO [11000028]

First Posted:

Oct 16, 2018

Last Update Posted:

Nov 12, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexa Craig, Assistant Professor of Pediatrics, MaineHealth

Hypothermia, Induced

Telemedicine

Hospitals, Community

Additional relevant MeSH terms:

Brain Diseases

Hypothermia

Study Results

No Results Posted as of Nov 12, 2021