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Telemedicine

Telemedicine for Neonatal Encephalopathy

N/A

Waitlist Available

Led By Alexa K Craig, MD

Research Sponsored by MaineHealth

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 10 days of life

Awards & highlights

Study Summary

This trial is testing whether telemedicine can help doctors diagnose newborns with encephalopathy, a key factor in deciding whether to treat them with therapeutic hypothermia.

Who is the study for?

This trial is for newborns with potential brain issues, specifically neonatal encephalopathy. They must have certain umbilical cord blood pH levels or need respiratory support after birth. Newborns older than 6 hours, under a specific gestational age or weight, or with non-English speaking parents are not eligible.Check my eligibility

What is being tested?

The study tests the use of telemedicine consultations twice within the first six hours of life to evaluate and potentially treat neonatal encephalopathy using therapeutic hypothermia if needed. The babies' health will be monitored through EEG and MRI until hospital discharge.See study design

What are the potential side effects?

Since this trial involves assessments rather than medications, there are no direct side effects from interventions like drugs. However, there may be indirect effects from handling the baby during evaluations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 10 days of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 10 days of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 10 days 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

Combined outcome of seizure or brain Injury on imaging

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telemedicine armExperimental Treatment1 Intervention

Neonates will have telemedicine consultation to evaluate symptoms of neonatal encephalopathy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telemedicine consult

2018

N/A

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MaineHealthLead Sponsor

71 Previous Clinical Trials

49,284 Total Patients Enrolled

3 Trials studying Neonatal Encephalopathy

162 Patients Enrolled for Neonatal Encephalopathy

Alexa K Craig, MDPrincipal Investigatorphysician

1 Previous Clinical Trials

34 Total Patients Enrolled

1 Trials studying Neonatal Encephalopathy

34 Patients Enrolled for Neonatal Encephalopathy

Media Library

Telemedicine (Telemedicine) Clinical Trial Eligibility Overview. Trial Name: NCT05155111 — N/A

Neonatal Encephalopathy Research Study Groups: Telemedicine arm

Neonatal Encephalopathy Clinical Trial 2023: Telemedicine Highlights & Side Effects. Trial Name: NCT05155111 — N/A

Telemedicine (Telemedicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155111 — N/A

Frequently Asked Questions

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

Is this study open to participants who are over thirty years of age?

"This trial is restricted to neonates with age parameters ranging from 0 hours up to 6 hours."

Answered by AI

Who is eligible to take part in this clinical investigation?

"This clinical trial seeks 150 neonates suffering from neurological issues. Candidates must be younger than 6 hours and meet specific criteria, such as a perinatal event (e.g., umbilical cord prolapse/rupture or cardiopulmonary arrest) , need for respiratory assistance of over 10 minutes not caused by primary pulmonary processes, and an Apgar score lower than 5 after 10 minutes."

Answered by AI

How many individuals are currently participating in this medical trial?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical trial is actively recruiting 150 individuals from 3 different sites. The investigation was first published on December 22nd 2021 and most recently updated in December of 2022."

Answered by AI

Will new participants be accepted into this experiment?

"The details of this clinical trial, which were first presented on December 22nd 2021 and have since been updated 12/1/2022, indicate that it is currently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy

Alexa Craig 2021. "Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155111.