Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000659505
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
25/06/2015
Date last updated
25/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bowel Motility Patterns in Newborns
Scientific title
A Pilot Study of Bowel Motility Patterns over the First Three Days of Life using the Littmann Electronic Stethoscope 3200
Secondary ID [1] 286802 0
Nil
Universal Trial Number (UTN)
Trial acronym
BSIB - bowel sounds in babies
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal bowel adaptation to extra-uterine life 295189 0
Condition category
Condition code
Oral and Gastrointestinal 295438 295438 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Auscultation of the newborn abdomen with the Littmann Electronic Stethoscope 3200, recording bowel sounds before during and after feeding for 1 minute on days 1, 2 and 3 of life and stimulating sucking reflex by either breast feeding or bottle feeding
Intervention code [1] 291963 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295172 0
Borborygmi as assessed by auscultation with the Littmann Electronic Stethoscope 3200
Timepoint [1] 295172 0
Three times a day over the first three days of life
Secondary outcome [1] 314941 0
nil
Timepoint [1] 314941 0
n/a

Eligibility
Key inclusion criteria
Term infants >36 completed weeks
Babies with Apgar scores greater than 7 at 1 and 5 minutes
Healthy newborns, not requiring any intervention except routine care such as IV fluids and antibiotics
Minimum age
1 Days
Maximum age
4 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Preterm infants<36 weeks at birth
Major congenital malformations
Babies that required active resuscitation at birth with Apgar scores less than 7 at 1 or 5 minutes
Babies that require any interventions other than routine care such IV fluids and antibiotics.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Audacity and SigmaPlot
Random selection of patients to assess the efficacy of the stethoscope and establish normal bowel patterns in normal babies
Our aim was to establish normal bowel patterns before, during and after feeding in this observational study. SO, sample size calculation was not possible without having any prior information in the literature on what’s normal in this age group. This is the reason we designed it as a prospective, time restricted, pilot observational study in which all the consecutive newborns born during a 6 month period were approached to participate in the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2012
Actual
5/03/2012
Date of last participant enrolment
Anticipated
26/10/2012
Actual
26/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291344 0
Self funded/Unfunded
Name [1] 291344 0
Dr Peter Campbell
Country [1] 291344 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Campbell
Address
Suite 16, lvl 7, Prince of Wales Private Hospital, Barker St, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 290038 0
None
Name [1] 290038 0
Address [1] 290038 0
Country [1] 290038 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57594 0
Dr Peter Campbell
Address 57594 0
Suite 16, Level 7, Prince of Wales Private Hospital, Barker St, Randwick, NSW, 2031
Country 57594 0
Australia
Phone 57594 0
+61 02 9650 4023
Fax 57594 0
Email 57594 0
[email protected]
Contact person for public queries
Name 57595 0
Charlotte Knox
Address 57595 0
Suite 16, Level 7, Prince of Wales Private Hospital, Barker St, Randwick, NSW, 2031
Country 57595 0
Australia
Phone 57595 0
+61 02 9650 4023
Fax 57595 0
Email 57595 0
[email protected]
Contact person for scientific queries
Name 57596 0
Charlotte Knox
Address 57596 0
Suite 16, Level 7, Prince of Wales Private Hospital, Barker St, Randwick, NSW, 2031
Country 57596 0
Australia
Phone 57596 0
+61 02 9650 4023
Fax 57596 0
Email 57596 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.