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Behavioural Intervention

Telemedicine for Neonatal Encephalopathy

N/A
Waitlist Available
Led By Alexa Craig, MD
Research Sponsored by MaineHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants will be younger than 6 hours of age at the time of the consultation
Infants will be in either high or moderate risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 6 hours of life
Awards & highlights

Study Summary

This trial will assess whether a teleconsult platform can help community hospital providers give therapeutic hypothermia to infants born with encephalopathy sooner, and whether providers will be satisfied with the platform.

Who is the study for?
This trial is for infants born in community hospitals in Maine who are younger than 6 hours old and at high or moderate risk of neonatal encephalopathy. High risk is defined by factors like low umbilical cord pH, low APGAR scores, need for resuscitation, abnormal exams, or seizures. Moderate risk involves slightly better but still concerning measures on these indicators.Check my eligibility
What is being tested?
The study tests a telemedicine platform called Maine Neonatal Encephalopathy Teleconsult (Maine NET) to see if it helps start therapeutic hypothermia (TH) treatment faster for newborns with brain issues compared to past methods without this technology. It also looks at how satisfied doctors are with using the platform.See study design
What are the potential side effects?
Since the intervention being tested is a telemedicine consult rather than a medical treatment, there are no direct side effects associated with its use as would be expected from medications or surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Babies will be less than 6 hours old when they are seen by the doctor.
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Infants who are at a high or moderate risk will be included.
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Babies who had a low umbilical cord pH, low APGAR score, needed resuscitation, had abnormal exams, or had seizures within 6 hours of birth will not be included.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 6 hours of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 6 hours of life for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to initiation of therapeutic hypothermia

Trial Design

1Treatment groups
Experimental Treatment
Group I: TelemedicineExperimental Treatment1 Intervention
Babies that received telemedicine consult intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telemedicine consult
2018
N/A
~140

Find a Location

Who is running the clinical trial?

MaineHealthLead Sponsor
71 Previous Clinical Trials
49,191 Total Patients Enrolled
3 Trials studying Neonatal Encephalopathy
69 Patients Enrolled for Neonatal Encephalopathy
Alexa Craig, MD4.36 ReviewsPrincipal Investigator - MaineHealth
MaineHealth
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Neonatal Encephalopathy
12 Patients Enrolled for Neonatal Encephalopathy
5Patient Review
Dr. Craig has always been my daughter's go-to medical professional, ever since she was born with spastic quadriplegic cerebral palsy. We appreciate her skill and honesty, and my family enjoys spending time with her because she's such a kind person.

Media Library

Telemedicine Consult (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03706417 — N/A
Neonatal Encephalopathy Research Study Groups: Telemedicine
Neonatal Encephalopathy Clinical Trial 2023: Telemedicine Consult Highlights & Side Effects. Trial Name: NCT03706417 — N/A
Telemedicine Consult (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03706417 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate number of individuals enrolled in this research?

"Affirmative, the clinicaltrials.gov website indicates that this research study has begun recruiting patients. This trial was first posted on April 30th 2018 and most recently updated on November 11 2021; they are looking to enroll 10 individuals from a single location."

Answered by AI

Are there any open slots for enrolment in this research endeavor?

"Clinicaltrials.gov confirms that this medical study is actively seeking volunteers; it was first advertised on April 30th 2018 and the details were updated most recently on November 11th 2021."

Answered by AI
~17 spots leftby Mar 2025