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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
congenital anomalies, grade 4 intraventricular haemorrhage or preiventricular malacia, oral anomaliess(tongue tie, cleft palate).

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
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] 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
Address [1] 289683 0
Medela AG,
Lattichstrasse 4b,
6341 Baar, Switzerland
Country [1] 289683 0
Primary sponsor type
Women's and Newborns' health service, WA
King Edward Hospital,
374 Bagot RD,
Subiaco 6008, WA, Australia
Secondary sponsor category [1] 288376 0
Commercial sector/Industry
Name [1] 288376 0
Address [1] 288376 0
Medela AG,
Lattichstrasse 4b,
6341 Baar, Switzerland
Country [1] 288376 0

Ethics approval
Ethics application status
Ethics committee name [1] 291421 0
Women's and Newborns Health Service Ethics Committee
Ethics committee address [1] 291421 0
King Edward Hospital
374 Bagot Rd,
Subiaco 6008, WA.
Ethics committee country [1] 291421 0
Date submitted for ethics approval [1] 291421 0
Approval date [1] 291421 0
Ethics approval number [1] 291421 0

Brief summary
The use of the novel teat to feed expressed breastmilk when mother not available to breastfeed preterm baby resulted in a shorter length of stay in hospital (2.5 days corrected for gestational age at discharge (p=0.026) and weight (p=0.006). Infants in the novel teat group had less formula feeding a discharge (novel 35%, control 16%, p=0.036) but otherwise did not differ in respect to feeding.
Trial website
Trial related presentations / publications
The trial results were presented at the scientific meetings of the Perinatal Society of Australia and New Zealand in Adelaide 2013 (Improving transition time from tube to sucking feeds in breastfed preterm infants - novel teat study. K Simmer, Y Kok, K Nancarrow, A Hepworth) and at the Pediatric Academic Societies inVancouver 2014(Novel feeding system to promote establishment of breastfeeding after preterm birth - randomised clinical trial. K Simmer, Y Kok, K Nancarrow, A Hepworth, D Geddes).
Public notes

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
Phone 50298 0
+61 8 93401262
Fax 50298 0
Email 50298 0
Contact person for public queries
Name 50299 0
Prof 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
Phone 50299 0
+61 8 93401262
Fax 50299 0
Email 50299 0
Contact person for scientific queries
Name 50300 0
Prof 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
Phone 50300 0
+61 8 93401262
Fax 50300 0
Email 50300 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary