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Remote monitoring for Infantile Spasms

N/A

Recruiting

Led By Jennifer D Coffman, BSN

Research Sponsored by University of Colorado, Denver

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 at therapy completion (end of week 4, with 7 days to complete)

Awards & highlights

Study Summary

This trial is studying whether a new telemedicine technology can help with parental stress, costs, and overall satisfaction in care for families who have children with a specific seizure type called infantile spasms.

Eligible Conditions

Infantile Spasms, Non-Intractable

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at therapy completion (end of week 4, with 7 days to complete)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at therapy completion (end of week 4, with 7 days to complete)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at therapy completion (end of week 4, with 7 days to complete) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare expenses between intervention group and control group

Compare overall satisfaction with treatment between intervention group and control group

Compare parental stress between intervention group and control group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

This group will be provided remote monitoring technology where they will be able to monitor blood pressure at home. In addition, they will receive a nurse-led telemedicine visit at one week and three weeks of therapy. Like the control group, they will still receive a two-week EEG and Neurology appointment.

Group II: Control GroupActive Control1 Intervention

This group will continue to receive standard care for ACTH monitoring and follow-up with includes blood pressure by the patient's PCP while on therapy, a one week nursing follow-up phone call, and a two-week EEG and Neurology appointment.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,188 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,843 Total Patients Enrolled

Jennifer D Coffman, BSNPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Remote monitoring Clinical Trial Eligibility Overview. Trial Name: NCT04086992 — N/A

Infantile Spasms Research Study Groups: Intervention Group, Control Group

Infantile Spasms Clinical Trial 2023: Remote monitoring Highlights & Side Effects. Trial Name: NCT04086992 — N/A

Remote monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04086992 — N/A

Frequently Asked Questions

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

Are applications being accepted for this experimental protocol?

"This clinical trial is still in need of participants, as indicated on the official listing hosted by clinicaltrials.gov. The initial post date for this study was October 10th 2019, and it has been actively updated until May 2nd 2022."

Answered by AI

What is the highest capacity for participants in this research endeavor?

"Affirmative. The information posted on clinicaltrials.gov indicates that this medical trial is currently enrolling volunteers; the original post was dated October 10th 2019 and it was last modified May 2nd 2022. This study necessitates 40 individuals from one specific location."

Answered by AI

Is the age of eligibility for this clinical trial greater than twenty years?

"Patients between one month and two-and-a-half years old are eligible to enroll in this medical research."

Answered by AI

Who meets the criteria for this medical experiment?

"In this research endeavour, the requisite enrollees must be under 30 months old, admitted at CHCO, Anschutz or Colorado Springs hospitals for initial ACTH treatments and suffering from limb cramps. Furthermore, their primary caretaker (parent/guardian) is necessary to complete enrollment. The trial has a cap of 40 participants in total."

Answered by AI

Recent research and studies

Annals of Indian Academy of NeurologyJournal

Infantile Spasms: A Prognostic Evaluation

Iype, Mary, Geetha Saradakutty, PuthuvathraAbdul Mohammed Kunju, Devi Mohan, Babu George, and ShahanazM Ahamed. 2016. “Infantile Spasms: A Prognostic Evaluation”. Annals of Indian Academy of Neurology. Medknow. doi:10.4103/0972-2327.173314.

Journal of Surgical ResearchJournal

Use of Digital Health Kits to Reduce Readmission After Cardiac Surgery

McElroy, Imani, Sohail Sareh, Allen Zhu, Gabrielle Miranda, Hoover Wu, Michelle Nguyen, Richard Shemin, and Peyman Benharash. 2016. “Use of Digital Health Kits to Reduce Readmission After Cardiac Surgery”. Journal of Surgical Research. Elsevier BV. doi:10.1016/j.jss.2016.04.028.

Blood Pressure MonitoringJournal

Determination of Accuracy in Neonates for Non-invasive Blood Pressure Device Using an Improved Algorithm

Nelson, Robert M., Andrea D. Stebor, Catherine M. Groh, Paula M. Timoney, Karen S. Theobald, and Bruce A. Friedman. 2002. “Determination of Accuracy in Neonates for Non-invasive Blood Pressure Device Using an Improved Algorithm”. Blood Pressure Monitoring. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00126097-200204000-00006.

Pediatric NeurologyJournal