SNOO Smart Sleeper for Infants With CHD

Completed

Conditions studied: Congenital Heart Disease, Infant Development, Technology

In brief

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.

Key facts

Study ID

NCT04534335

Run by

Children's Mercy Hospital Kansas City

People needed

11

Starts

2020-02-04

Expected to finish

2022-09-12

Last updated by the study team

2022-10-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• infants who have recently undergone cardiac surgery or cardiac catheterization for a stent for pulmonary blood flow at Children's Mercy Kansas City
• less than or equal to 6 months of age and under 11kg .

You may not qualify if…

• Greater than 6 months of age or over 11kg

Where it is running

• Children's Mercy Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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