COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
Trial acronym
BoSS Term
Linked study record

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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Babies who died or whose mothers are sick and unable to give consent.

Study design
Purpose of the study
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
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 status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 10647 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 22369 0
4814 - Douglas
Recruitment outside Australia
Country [1] 10280 0
State/province [1] 10280 0
KK Hospital

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

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
QLD 4814
Ethics committee country [1] 300126 0
Date submitted for ethics approval [1] 300126 0
Approval date [1] 300126 0
Ethics approval number [1] 300126 0

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
Trial related presentations / publications
Public notes

Principal investigator
Name 82646 0
Prof KOH Tieh Hee Hai Guan
Address 82646 0
The Townsville Hospital
100 Angus Smith Drive
QLD 4814
Country 82646 0
Phone 82646 0
Fax 82646 0
Email 82646 0
Contact person for public queries
Name 82647 0
Prof KOH Tieh Hee Hai Guan
Address 82647 0
100 Angus Smith Drive
The Townsville Hospital
QLD 4814
Country 82647 0
Phone 82647 0
Fax 82647 0
Email 82647 0
Contact person for scientific queries
Name 82648 0
Prof KOH Tieh Hee Hai Guan
Address 82648 0
The Townsville Hospital
100 Angus Smith Drive
QLD 4814
Country 82648 0
Phone 82648 0
Fax 82648 0
Email 82648 0

No information has been provided regarding IPD availability
Summary results
No Results