Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000745246p
Ethics application status
Submitted, not yet approved
Date submitted
12/04/2018
Date registered
4/05/2018
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel Sounds Sensor (BoSS) in term babies study.
Scientific title
Bowel Sounds Sensor (BoSS) in term well and sick babies study - evaluation of the effectiveness and efficacy of a non non-invasive continuous monitoring of bowel sounds.
Secondary ID [1] 294585 0
nil
Universal Trial Number (UTN)
U1111-1212-2913
Trial acronym
BoSS Term
Linked study record
no

Health condition
Health condition(s) or problem(s) studied:
Necrotising enterocolitis 307376 0
surgical bowel conditions 307377 0
Condition category
Condition code
Oral and Gastrointestinal 306481 306481 0 0
Inflammatory bowel disease
Reproductive Health and Childbirth 306555 306555 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detection of bowel sounds using a bowel sounds sensor AcronSensor manufactured by Docentron. A neonatal research nurse will apply the sensor pad using a double sided adhesive tape on the wall of the abdomen to collect 10 minutes of bowel sounds. Bowel sounds will be performed on term well babies and term unwell babies 24 hours after admission.
The nurse will document any issues with applying the sensor pad.
Intervention code [1] 300881 0
Diagnosis / Prognosis
Comparator / control treatment
The group consists of term well babies who serve as the control group.
The frequency, pitch, duration, decibel and wave form of the bowel sounds will be analysed and compared between the 2 groups of babies.
Control group
Active

Outcomes
Primary outcome [1] 305497 0
Outcome is assessed by the age when the baby tolerating of milk feeds in both well and unwell babies - these information will be obtained from the medical and nursing records in the baby's record.
Timepoint [1] 305497 0
Follow up up to 1 month of age.
Secondary outcome [1] 345468 0
The difference(s) in the characteristics (frequency, pitch, decibels, intervals between bowels sounds) of bowel sounds as detected by the bowel sounds sensors (Acronsensor by Docentron) between term normal babies and term sick babies.
Timepoint [1] 345468 0
Secondary time point - the characteristics of the bowel sounds are obtained when the babies 12 hours after the babies become unwell with clinical features of bowel problems (eg vomiting, bilious gastric aspirates, bowel distension, blood in the stools) and when they are able to tolerate full enteral feeds.

Eligibility
Key inclusion criteria
Term well babies in maternity and term unwell babies in NICU in Townsville Hospital, Queensland and KK Hospital Singapore..
Minimum age
1 Hours
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Babies who died or whose mothers are sick and unable to give consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis will take into account of maternal data (eg infection, medication used which may impact of gut motility eg magnesium sulphate) and baby data (eg asphyxia, surgical bowel conditions, medications used).. Dr Insu SONG, an IT engineer specialist at JCU Singapore, will analyse and compare the characteristic of the bowel sounds in term well babies and term sick babies to identify any significant differences between the 2 groups.. The sample size is based on a convenience sample as this is a pilot study to evaluate the efficacy of obtaining bowel sounds using the AcronSensor).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10647 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 22369 0
4814 - Douglas
Recruitment outside Australia
Country [1] 10280 0
Singapore
State/province [1] 10280 0
KK Hospital

Funding & Sponsors
Funding source category [1] 299201 0
Hospital
Name [1] 299201 0
SERTA (Study, Education and Research Trust account) -Townsville Hospital
Country [1] 299201 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
The Townsville Hospital Health Service
100 Angus Smith
Douglas
QLD 4814
Country
Australia
Secondary sponsor category [1] 298464 0
Hospital
Name [1] 298464 0
KK Hospital
Address [1] 298464 0
NICU
KK Hospital
100 Bukit Timah Road, Singapore 229899
Country [1] 298464 0
Singapore

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300126 0
Townsville Hospital Human Research Ethics Committee
Ethics committee address [1] 300126 0
The Townsville Hospital Health Service
100 Angus Smith Drive
Douglas
QLD 4814
Ethics committee country [1] 300126 0
Australia
Date submitted for ethics approval [1] 300126 0
23/04/2018
Approval date [1] 300126 0
Ethics approval number [1] 300126 0

Summary
Brief summary
Currently, we use a stethoscope to listen to the bowel sounds during examination of the newborn baby. We have now a simple sensor the size of a 20 cent coin, which when placed on the surface of your baby’s abdomen, can pick up bowel sounds without disturbing the baby.

Purpose of this study
We want to check the usefulness of the new method in picking up bowel sounds in newborn term babies and term sick babies..

What does this study involve?

We would like your help with making a 10 minutes recording of bowel sounds in well babies – for 5 minutes before and 5 minutes after a feed in healthy well term and near term babies who are in the NICU. Having recordings of normal bowel sounds may allow us to use the bowel sounds sensor to help babies who are unwell. The bowel sounds sensor may allow us to detect early bowel problems in sick babies and also help us to decide the right time to start feeding in sick babies who are recovering.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 82646 0
Prof KOH Tieh Hee Hai Guan
Address 82646 0
NICU
The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 82646 0
Australia
Phone 82646 0
+61487149593
Fax 82646 0
+61744332981
Email 82646 0
[email protected]
Contact person for public queries
Name 82647 0
Prof KOH Tieh Hee Hai Guan
Address 82647 0
NICU
100 Angus Smith Drive
The Townsville Hospital
Douglas
QLD 4814
Country 82647 0
Australia
Phone 82647 0
+61487149593
Fax 82647 0
+61744332981
Email 82647 0
[email protected]
Contact person for scientific queries
Name 82648 0
Prof KOH Tieh Hee Hai Guan
Address 82648 0
NICU
The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 82648 0
Australia
Phone 82648 0
+61487149593
Fax 82648 0
+61744332981
Email 82648 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
No additional documents have been identified.