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Trial registered on ANZCTR


Registration number
ACTRN12614000875606
Ethics application status
Approved
Date submitted
29/07/2014
Date registered
14/08/2014
Date last updated
14/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel feeding system to promote the establishment of breastfeeding after preterm birth a randomised controlled trial.
Scientific title
Effect of a novel teat feeding system on breast feeding and length of hospital stay in preterm infants.
Secondary ID [1] 285077 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 292605 0
Condition category
Condition code
Reproductive Health and Childbirth 292918 292918 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
novel teat that releases milk only when the infant sucks with sufficient vacuum to release valve. The teat was offered only when mother was not available to breastfeed and when a bottle feed was scheduled, until discharge from hospital. Mother's expressed breastmilk was the feed of choice. Pastuerised donor human milk was available for those infants < 34 weeks gestation as an alternative and for those > 34 weeks, gestation, preterm formula was used when mother's expressed breastmilk was not available.
Intervention code [1] 289914 0
Treatment: Devices
Comparator / control treatment
routine care using standard teat that allows milk flow with gravity and compression of teat.
Control group
Active

Outcomes
Primary outcome [1] 292782 0
rates of breastfeeding (any breast-feeding)
Timepoint [1] 292782 0
discharge from hospital
Primary outcome [2] 292835 0
length of stay in hospital
Timepoint [2] 292835 0
discharge home
Primary outcome [3] 292836 0
transition from first suck feed (when bottle or breastfeed offered and any sucked e some or all of feed) to full breastfeeds (all breastfeeds). Clinical staff and mothers determined when suck feed either bottle or breast was offered.
Timepoint [3] 292836 0
when full breastfeeding established
Secondary outcome [1] 309671 0
sucking vacuum and tongue movements during suck feeds and measured by ultrasound.
Timepoint [1] 309671 0
during a suck feed using novel teat and during a breastfeed at a time convenient to mothers and usually in the week before discharge,
Secondary outcome [2] 309772 0
frequency of bottle feeding was ascertained by telephone call to mothers.
Timepoint [2] 309772 0
3, 6 and 12 weeks post discharge from hospital

Eligibility
Key inclusion criteria
preterm infants born at 25-34 weeks gestation at King Edward Hospital, Perth, and whose mothers intended to breastfeed
Minimum age
3 Days
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
congenital anomalies, grade 4 intraventricular haemorrhage or preiventricular malacia, oral anomaliess(tongue tie, cleft palate).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
infants randomised once full enteral feeds established
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sealed opaque coded envelopes containing computer generated treatment allocation were sequentially numbered and used for randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
R 2.9.0 for Mac OS X with additional packages nlme and lattice. analysis on intention to treat basis.
Sample size of at least 60 infants was determined based on the ability to determine a 3-day difference in length of hospital stay, p value<0.05.
As per our ethics approval initially, we enrolled 30 infants (15 in each
arm) as an internal pilot study in the first 3 months of the study period.
This data was be used to determine final sample size. Pragmatically, we endeavoured to enrol all eligible infants admitted to the NICU to achieve a statistical power to detect a decrease in length of stay in hospital (primary endpoint) of at least 3 days for each infant. Given that a total of 187 infants of <33 wks GA were admitted during July-Dec 2010, we expected recruitment will be complete within 6 months.

Following the pilot study a sample size of 30 in each group, as determined by a power calculation, was required to show a difference in length of stay of 3 days.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2011
Actual
3/08/2011
Date of last participant enrolment
Anticipated
Actual
16/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2793 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 8483 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 289683 0
Commercial sector/Industry
Name [1] 289683 0
Medela
Country [1] 289683 0
Switzerland
Primary sponsor type
Hospital
Name
Women's and Newborns' health service, WA
Address
King Edward Hospital,
374 Bagot RD,
Subiaco 6008, WA, Australia
Country
Australia
Secondary sponsor category [1] 288376 0
Commercial sector/Industry
Name [1] 288376 0
Medela
Address [1] 288376 0
Medela AG,
Lattichstrasse 4b,
6341 Baar, Switzerland
Country [1] 288376 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291421 0
Women's and Newborns Health Service Ethics Committee
Ethics committee address [1] 291421 0
Ethics committee country [1] 291421 0
Australia
Date submitted for ethics approval [1] 291421 0
Approval date [1] 291421 0
05/07/2011
Ethics approval number [1] 291421 0

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

Contacts
Principal investigator
Name 50298 0
Prof Karen Simmer
Address 50298 0
Centre for Neonatal Research and Education,
M551 University of Western Australia,
35 Stirling Highway,
Crawley, Perth 6009.
Country 50298 0
Australia
Phone 50298 0
+61 8 93401262
Fax 50298 0
Email 50298 0
karen.simmer@health.wa.gov.au
Contact person for public queries
Name 50299 0
Karen Simmer
Address 50299 0
Centre for Neonatal Research and Education,
M551 University of Western Australia,
35 Stirling Highway,
Crawley, Perth 6009.
Country 50299 0
Australia
Phone 50299 0
+61 8 93401262
Fax 50299 0
Email 50299 0
Karen.simmer@health.wa.gov.au
Contact person for scientific queries
Name 50300 0
Karen Simmer
Address 50300 0
Centre for Neonatal Research and Education,
M551 University of Western Australia,
35 Stirling Highway,
Crawley, Perth 6009.
Country 50300 0
Australia
Phone 50300 0
+61 8 93401262
Fax 50300 0
Email 50300 0
karen.simmer@health.wa.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseNovel feeding system to promote establishment of breastfeeds after preterm birth: A randomized controlled trial.2016https://dx.doi.org/10.1038/jp.2015.184
Dimensions AIPreterm Infant Feeding: A Mechanistic Comparison between a Vacuum Triggered Novel Teat and Breastfeeding2018https://doi.org/10.3390/nu10030376
N.B. These documents automatically identified may not have been verified by the study sponsor.