Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

Neonatal Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706417
• Other study ID #: MMP PEDIATRIC NEURO [11000028]
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will recruit a total of 125 infants from the participating centers and anticipate that 35 of these subjects will be treated with therapeutic hypothermia and be utilized for the comparative analysis to historical controls. Not all infants recruited and provided a Maine NET consultation will be treated with TH and to have an adequate sample size to make statistical comparisons with historical controls we need to enroll more than 35 participants to ensure 35 have been treated with TH for the comparative analysis.

In a secondary qualitative study, clinicians who completed Maine NET consults through the above clinical trial were interviewed about their experience with the consult. This secondary study will recruit up to 20 clinicians who completed a consult in this clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hypothermia
• Neonatal Encephalopathy

Intervention

Diagnostic Test:
• Telemedicine consult
Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
MaineHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initiation of therapeutic hypothermia	Time to initiation of therapeutic hypothermia	First 6 hours of life