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Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

Primary Purpose

Neonatal Encephalopathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telemedicine consult

About this trial

This is an interventional diagnostic trial for Neonatal Encephalopathy focused on measuring Hypothermia, Induced, Telemedicine, Hospitals, Community

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept 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.

Sites / Locations

Maine Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine

Historical control

Arm Description

Babies that received telemedicine consult intervention.

Historical controls who have not received a telemedicine consult.

Outcomes

Primary Outcome Measures

Time to initiation of therapeutic hypothermia

Secondary Outcome Measures

Full Information

NCT ID

NCT03706417

First Posted

October 11, 2018

Last Updated

October 21, 2023

Sponsor

MaineHealth

1. Study Identification

Unique Protocol Identification Number

NCT03706417

Brief Title

Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 30, 2018 (Actual)

Primary Completion Date

July 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Encephalopathy

Keywords

Hypothermia, Induced, Telemedicine, Hospitals, Community

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telemedicine

Arm Type

Experimental

Arm Description

Babies that received telemedicine consult intervention.

Arm Title

Historical control

Arm Type

No Intervention

Arm Description

Historical controls who have not received a telemedicine consult.

Intervention Type

Diagnostic Test

Intervention Name(s)

Telemedicine consult

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to initiation of therapeutic hypothermia

Description

Time to initiation of therapeutic hypothermia

Time Frame

First 6 hours of life

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Hours

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexa Craig, MD

Phone

2073967337

craiga@mmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tho Ngo

Phone

2076622703

ngot@mainehealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexa Craig, MD

Organizational Affiliation

MaineHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexa Craig, MD

Phone

207-396-7337

craiga@mmc.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

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