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SNOO Smart Sleeper for Infants With CHD

NCT04534335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2022-10-06

No results posted yet for this study

Summary

Study Title The SSSH Study: SNOO Smart Sleeper Use in Post-Operative Infants with Congenital Heart Disease is a single site, cross-sectional, feasibility study of an infant smart sleeper. The Primary Objective is to evaluate the feasibility of collecting and integrating clinical data and SNOO data. The secondary Objective(s) is To assess the feasibility of conducting a future broader trial by evaluating the parents willingness to give parental permission for participation in the use of the SNOO. Research Intervention(s)/ Investigational Agent(s) SNOO Smart Sleeper from Happiest Baby, Inc.There are approximately 300 new infants per year who undergo cardiac surgery at Children's Mercy Kansas City (CMKC) who are 6 months of age and 11kg or less at the time of surgery Sample Size. A maximum of 15 patients will be enrolled for this feasibility study over the study Duration for Individual Participant Length of hospitalization on 4Sutherland, average length of stay for this patient population is 30 days.

Conditions

  • Congenital Heart Disease
  • Infant Development
  • Technology

Interventions

DEVICE

SNOO Smart Sleep from Happiest Baby, Inc

Data related to the use of the SNOO itself (collected electronically) such as the amount of movement provided by the SNOO, etc., will be examined with the hemodynamic data obtained during the use of the SNOO. Clinical care data as it relates to the child will also be evaluated as it pertains to the use of the SNOO (this information will focus on the amount and frequency of narcotics administered to the infant). feasibility of use is the device intervention.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Shannon Lysaught, BSN, MBA · Children's Mercy

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2022-05-28
Completion
2022-09-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534335 on ClinicalTrials.gov