Status:

UNKNOWN

Decreasing Parental Stress of Caregivers of Infants With Infantile Spasms by Using Telemedicine Technology

Lead Sponsor:

University of Colorado, Denver

Collaborating Sponsors:

Mallinckrodt

Conditions:

Infantile Spasms, Non-Intractable

Eligibility:

All Genders

31-30 years

Phase:

NA

Brief Summary

This study plans to learn more about how the use of new telemedicine technology can help with parental stress, costs, and overall satisfaction in care. Investigators are studying this in families who ...

Detailed Description

Infantile Spasms, historically call West Syndrome, is an infantile epileptic encephalopathy, typically occurring within the first two years of life. Infantile Spasms is often characterized by hypsarrh...

Eligibility Criteria

Inclusion

  • Patients admitted to CHCO, Anschutz and Colorado Springs hospitals, under the age of 30 months with a primary diagnosis of Infantile Spasms and started on first-time ACTH and their primary caregiver (parent/guardian).

Exclusion

  • Infants with recurrent Infantile Spasms and retreatment with ACTH and their primary caregiver (parent/guardian).
  • Infants with existing home health nursing services and their primary caregiver (parent/guardian).
  • Infants with prolonged inpatient admissions beyond 7 days after initiation on ACTH and their primary caregiver (parent/guardian).
  • Infants whose caregivers do not read, write, and/or speak English with sufficient proficiency to provide informed consent and their primary caregiver (parent/guardian).
  • Neonates less than 31 days old and their primary caregiver (parent/guardian).
  • Infants that have been hospitalized since birth and their primary caregiver (parent/guardian).
  • Infants that are wards of the state and their primary caregiver (guardian).
  • Infants that reside in a geographic location with no major network cell service and their primary caregiver (parent/guardian).

Key Trial Info

Start Date :

October 10 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 30 2023

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04086992

Start Date

October 10 2019

End Date

October 30 2023

Last Update

May 4 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045