Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001491257p
Ethics application status
Submitted, not yet approved
Date submitted
20/08/2018
Date registered
5/09/2018
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of SmartSnugg Infant Sleeping Bags
Scientific title
Validation of SmartSnugg Infant Sleeping Bags
Secondary ID [1] 295794 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Unexpected Death in Infancy 309305 0
Condition category
Condition code
Respiratory 308175 308175 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will validate a new product the SmartSnugg Baby Sleeping Bag that records the baby’s temperature and sleeping position while asleep and displays this for parents to check. The SmartSnugg uses a “pebble” which is contained in a pouch and is removable so it can be used in different sleeping bags and also for washing of the sleeping bag. The pebble incorporates an ambient temperate sensor, accelerometer and Ultra Low Power Bluetooth transmitter that communicates with a WIFI bridge in the child’s room. The WIFI bridge also incorporates an ambient temperature sensor so that the child’s room temperature can be monitored. The information captured from the pebble and bridge (temperature, movement, position) are received and routed from the SmartSnugg bridge through the users home WIFI network before being stored and analysed in the cloud. The information is then displayed to parents and caregivers on their mobile phone or tablet.

The validation study will record temperature from accurate temperature sensors placed on the abdomen and limbs while the baby sleeps and compare these measurements to the output of the SmartSnugg. Sleep position and room temperature will also be confirmed.
Recruitment: The study will be advertised on Monash University and Monash Health Newsletters and to local Maternal and Child Health Centre and Crèches. Parents of healthy babies aged 3 and 6 months will be invited to participate. Parents will contact Prof Horne and after discussion of the time commitments and methods to be used in the study she will email or post the parent information sheet. If parents agree to the research study a suitable time for the study will be scheduled. Parents will sign the parent information and consent form before the study commences. 20 healthy infants born at term will be recruited and studied at 3 months (n=10) and 6 months (n=10) of age.
Methods: Infants will be studied in a quiet room at the Monash Children’s Hospital.
Four different SmartSnugg Infant Sleeping Bags will be tested:
1. 0-3 month 1 tog
2. 0-3 month 2.5 tog
3. 3-12 month 1 tog
4. 3-12 month 2.5 tog.
Infants will sleep have both a morning and afternoon sleep. They will sleep for 1-2 hours in each thickness of sleeping bag appropriate for their age. Studies will last 5-6 hours.
Sleep state will be recorded using behavioural observations of eye movements and breathing and heart rate patterns as active sleep (AS) or quiet sleep (QS). Chest and abdominal wall motion (ProTech z-RIP belts, Pro-Tech Services, Inc. Mukilteo, WA, USA), pulse oxygen saturation (Masimo Radical, Masimo Corporation, CA, USA), oronasal airflow and nasal pressure (Compumedics, Melbourne, Vic, Australia) will be recorded to assess breathing patterns. Skin temperature will be recorded from the trunk and limbs (4 probes in total) (ADInstruments, Sydney, NSW, Australia). All signals will be recorded onto and E-series Sleep System (Compumedics, Melbourne, Vic, Australia).
All studies will be transferred via EDF format to specialised analysis software PowerLab (Chart, ADInstruments, Sydney, NSW, Australia). Sleep state in infants will be scored as AS or QS according to standard criteria for infants. Apnoeas will be defined as those respiratory events lasting =3 s and will be classified as central, obstructive, or mixed apnoeas, central or obstructive hypopnoea. Periodic breathing episodes will be defined as 3 or more sequential central apnoeas lasting greater or equal to 3 s interrupted by breathing lasting greater or equal to 20 s.
Total sleep time, sleep epoch lengths and the frequency of sleep state changes will be documented. Sleep position will be recorded. Infant skin temperature will be compared with the temperature recorded by the SmartSnugg with paired Student’s T-Tests. Data will be presented as mean ± SEM with a p value <0.05 take as being statistically significant.
Baby weight will be recorded from infant health book.
Expected Outcomes
We expect that the temperature recorded by the SmartSnugg will not differ from that recorded from the infant.
Intervention code [1] 312191 0
Other interventions
Comparator / control treatment
There is no control group each baby will sleep in one of two thicknesses of SmartSnugg sleeping bag which is appropriate for their age. Comparison will be made of the temperature recorded from the skin sensors and the SmartSnugg for each thickness and size of sleeping bag.
Control group
Active

Outcomes
Primary outcome [1] 307145 0
Comparison of temperature measured by the SmartSnugg and that measured from the baby
Timepoint [1] 307145 0
10 infants will be assessed at 3 months and 10 at 6 months of age during a morning and afternoon sleep.
Secondary outcome [1] 350901 0
Changes in sleep patterns as assessed by using behavioural observations of eye movements and breathing and heart rate patterns as active sleep (AS) or quiet sleep (QS).
Timepoint [1] 350901 0
10 infants will be assessed at 3 months and 10 at 6 months of age during a morning and afternoon sleep.
Secondary outcome [2] 351115 0
Changes in breathing will be assessed using chest and abdominal wall motion (ProTech z-RIP belts, Pro-Tech Services, Inc. Mukilteo, WA, USA) and oronasal airflow and nasal pressure (Compumedics, Melbourne, Vic, Australia),
Timepoint [2] 351115 0
10 infants will be assessed at 3 months and 10 at 6 months of age during a morning and afternoon sleep.
Secondary outcome [3] 351116 0
Changes in heart rate as assessed using electrocardiogram electrodes.
Timepoint [3] 351116 0
10 infants will be assessed at 3 months and 10 at 6 months of age during a morning and afternoon sleep.

Eligibility
Key inclusion criteria
Healthy babies born at term who are aged 3 months and 6 months
Minimum age
3 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
infants born preterm or which a medical condition affecting sleep and breathing

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is a convenience sample of 10 babies at 3 months and 10 at 6 months. Temperature measurements between that recorded by the SmartSnugg and directly from the baby will be compared using a paired Student's T-Test. We expect an accuracy of 1 degree C between the 2 measurements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2018
Actual
Date of last participant enrolment
Anticipated
20/12/2018
Actual
Date of last data collection
Anticipated
20/12/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 23768 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300386 0
Commercial sector/Industry
Name [1] 300386 0
SmartSnugg
Country [1] 300386 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Paediatrics, Monash Children's Hospital, 246 Clayton Road, Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 299917 0
None
Name [1] 299917 0
Address [1] 299917 0
Country [1] 299917 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301195 0
Monash Health Human Research Ethic Committee
Ethics committee address [1] 301195 0
Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168
Ethics committee country [1] 301195 0
Australia
Date submitted for ethics approval [1] 301195 0
31/05/2018
Approval date [1] 301195 0
Ethics approval number [1] 301195 0

Summary
Brief summary
Keeping a baby’s head and face uncovered during sleep is an important part of safe sleeping for babies to prevent Sudden Unexpected Death in Infancy (SUDI). It is also important to not to let babies become overheated while they sleep. Increasingly infant sleep bags are being used to keep babies sleeping safely. Sleeping babies in a safe baby sleeping bag, one designed especially for baby, with fitted neck and armholes and no hood, has a number of features that help baby sleep safely. Research has shown that sleeping bag use reduces the risk of bedclothes covering the baby’s face, and delays the baby rolling onto the tummy during sleep until baby is past the age of peak risk of SUDI. Supine sleep is also promoted when the zipper is opened to the front.

In this study we will validate a new SmartSnugg infant sleeping bag which records and displays the temperature inside the sleeping bag so that parents can easily monitor this. Infants will be studied during sleep in two different thicknesses of SmartSnugg to assess if the SmartSnugg accurately records baby temperature. The company SmartSnugg are funding the Hudson Research Institute to conduct this study.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3000 3000 0 0
/AnzctrAttachments/375781-SmartSnugg protocol.docx (Protocol)
Attachments [2] 3001 3001 0 0
/AnzctrAttachments/375781-SmartSnugg Information sheet version 2 July 2018.docx (Participant information/consent)
Attachments [3] 3002 3002 0 0
/AnzctrAttachments/375781-Approval Subject to Conditions Letter - HREC Ref No. RES-18-0000-359A.pdf (Ethics approval)

Contacts
Principal investigator
Name 86182 0
Prof Rosemary Horne
Address 86182 0
Department of Paediatrics, Level 5, Monash Children's Hospital, 246 Clayton Road, Clayton Victoria 3168
Country 86182 0
Australia
Phone 86182 0
+61385722827
Fax 86182 0
Email 86182 0
[email protected]
Contact person for public queries
Name 86183 0
Mr Matthew Hearsch
Address 86183 0
Hearsch Industries 28 Chandos Crt St Albans Park Victoria 3219.
Country 86183 0
Australia
Phone 86183 0
+61431321629
Fax 86183 0
Email 86183 0
[email protected]
Contact person for scientific queries
Name 86184 0
Prof Rosemary Horne
Address 86184 0
Department of Paediatrics, Level 5, Monash Children's Hospital, 246 Clayton Road, Clayton Victoria 3168
Country 86184 0
Australia
Phone 86184 0
+61385722827
Fax 86184 0
Email 86184 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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