SNOO Smart Sleeper for Infants With CHD (SHHH's)

October 4, 2022 updated by: Lori Erickson, Children's Mercy Hospital Kansas City

The SSSH's: SNOO Smart Sleeper Use in Post-Operative Infants With Congenital Heart

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants with congenital heart disease (CHD) are a low frequency but high acuity and stress population in the pediatric hospital setting. There are approximately 300 patients admitted a year that require cardiac surgery and are under the age of 6 months at Children's Mercy. These patients may spend less time in the hospital, but the care they require is often complex resulting in potential hemodynamic changes and pain responses for the infants. Smart technologies are used in CHD populations like single ventricle interstage monitoring at home, CHAMP App, but there are opportunities for baby-parent-nurse in-hospital smart solutions such as the SNOO Smart Sleeper bassinet by Happiest Baby INC . The SNOO Smart Sleeper has been used in more than 20 other hospitals across the country, including The University of Kansas Health System, mainly for infants related to preterm or neonatal abstinence syndrome (NAS). The SNOO utilizes some of the components of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) to aid as physical interventions for infant pain. This has been shown to be effective for pain reduction and less crying time after painful procedures . The calming response for infants has been seen to improve with soothing of the infant through supine mechanical movement, swaddling, and sound . A prospective observational cohort of preterm (32-36 weeks GA) neonates found that intermittent hypoxia and bradycardia significantly declined after use of womb-like soothing sound. The auditory neural pathways have close anatomical connection to the autonomic nervous system and the potential for auditory to parasympathetic response and reduced cardiac and respiratory rates are intriguing for evaluation in the infant population after cardiac surgery. The SNOO has yet to be used in the post-operative pediatric CHD population in the inpatient setting. The success in other fragile infant populations lends to a possible new area for use in the high risk CHD population in the post-operative recovery phase related to pain and hemodynamic changes.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Only the families of patients that have already undergone a procedure for congenital heart disease will be approached for participation in this study. All female and male infants will qualify.

Description

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • Greater than 6 months of age or over 11kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of time of utilization of SNOO for each infant
Time Frame: 6 months
Feasibility of new device for use in the pediatric cardiac surgery infant population
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of parents receptive to use of the SNOO
Time Frame: 6 months
Total number of parents consenting for feasibility trial
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Shannon Lysaught, BSN, MBA, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2020

Primary Completion (Actual)

May 28, 2022

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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