SNOO Smart Sleeper for Infants With CHD

NCT04534335 | Completed FDA Device

• 1 other identifier: STUDY00001376
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Congenital Heart disease; Infant Sleep

Outcome Measures

Primary Outcomes (1)

• Length of time of utilization of SNOO for each infant

  Feasibility of new device for use in the pediatric cardiac surgery infant population

  6 months

Secondary Outcomes (1)

• Number of parents receptive to use of the SNOO

  6 months

Interventions

SNOO Smart Sleep from Happiest Baby, Inc DEVICE

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.

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• Harrington JW, Logan S, Harwell C, Gardner J, Swingle J, McGuire E, Santos R. Effective analgesia using physical interventions for infant immunizations. Pediatrics. 2012 May;129(5):815-22. doi: 10.1542/peds.2011-1607. Epub 2012 Apr 16.

  PMID: 22508924 BACKGROUND

• Moller EL, de Vente W, Rodenburg R. Infant crying and the calming response: Parental versus mechanical soothing using swaddling, sound, and movement. PLoS One. 2019 Apr 24;14(4):e0214548. doi: 10.1371/journal.pone.0214548. eCollection 2019.

  PMID: 31017930 BACKGROUND

• Parga JJ, Bhatt RR, Kesavan K, Sim MS, Karp HN, Harper RM, Zeltzer L. A prospective observational cohort study of exposure to womb-like sounds to stabilize breathing and cardiovascular patterns in preterm neonates. J Matern Fetal Neonatal Med. 2018 Sep;31(17):2245-2251. doi: 10.1080/14767058.2017.1339269. Epub 2017 Jun 22.

  PMID: 28587528 BACKGROUND

Related Links

• Happiest Baby, Inc 2020

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shannon Lysaught, BSN, MBA

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Remote Health Solutions, PhD

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: February 4, 2020
• Primary Completion: May 28, 2022
• Study Completion: September 12, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)