Congenital Heart DiseaseSHHH'sNCT04534335
SNOO Smart Sleeper for Infants With CHD
An observational study of Congenital Heart Disease and Infant Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Heart Disease, Infant Development, Technology
- What is being tested?
- SNOO Smart Sleep from Happiest Baby, Inc
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 12 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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 .
Who cannot join
- Greater than 6 months of age or over 11kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Kansas City
Kansas City, Missouri, 64108
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease, Infant Development, Technology
- Being tested
- SNOO Smart Sleep from Happiest Baby, Inc
- Keywords
- Congenital Heart disease, Infant Sleep
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNOO Smart Sleep from Happiest Baby, IncDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time of utilization of SNOO for each infant
Feasibility of new device for use in the pediatric cardiac surgery infant population
Measured: 6 months
Secondary outcomes (1)
Number of parents receptive to use of the SNOO
Total number of parents consenting for feasibility trial
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start4 Feb 2020
- Primary completion28 May 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Erickson, Children's Mercy Hospital Kansas City
- Investigators
- Shannon Lysaught, BSN, MBA, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534335
- Sponsor's protocol ID
- STUDY00001376
- Acronym
- SHHH's
- Status last verified
- Oct 2022
- First submitted
- 27 Aug 2020
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22508924Moller 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.
PubMed 31017930Parga 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.
PubMed 28587528
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SSSH's: SNOO Smart Sleeper Use in Post-Operative Infants With Congenital Heart
- ClinicalTrials.gov ID
- NCT04534335
- Acronym / sponsor ID
- SHHH's / STUDY00001376
- Conditions
- Congenital Heart Disease, Infant Development, Technology
- Keywords
- Congenital Heart disease, Infant Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (1 listed)
- Greater than 6 months of age or over 11kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNOO Smart Sleep from Happiest Baby, IncData 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. | Device | – |
Primary outcome
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
1 secondary outcome
Number of parents receptive to use of the SNOO
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 22508924Harrington 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.
- Background: PubMed 31017930Moller 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.
- Background: PubMed 28587528Parga 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.
- Happiest Baby, Inc 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Lysaught, BSN, MBA principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Infant Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time of utilization of SNOO for each infant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.