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NCT04534335 · ClinicalTrials.gov registry record
SNOO Smart Sleeper for Infants With CHD
A clinical trial, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- 11
- Enrollment target
NCT04534335: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT04534335 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534335 has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- 11 participants
- Enrollment target
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.
Primary Outcome
Feasibility of new device for use in the pediatric cardiac surgery infant population
Interventions
- DEVICE SNOO Smart Sleep from Happiest Baby, Inc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2022-09-12 |
What the finished NCT04534335 record still lists
NCT04534335 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SNOO Smart Sleep from Happiest Baby, Inc is the first listed.
NCT04534335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534335 about?
NCT04534335 is a clinical study titled "SNOO Smart Sleeper for Infants With CHD". 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. ...
What is the current status of trial NCT04534335?
This trial is currently completed. The enrollment target is 11 participants. The study started on 2020-02-04. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT04534335?
The interventions under investigation include: SNOO Smart Sleep from Happiest Baby, Inc (DEVICE).
Who is sponsoring clinical trial NCT04534335?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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