Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000661673
Ethics application status
Approved
Date submitted
10/05/2014
Date registered
24/06/2014
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Date results provided
10/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Taste and Smell to improve milk tolerance in preterm infants
Scientific title
Exposing preterm infants to the taste and smell of their milk, or not exposing them to the taste and smell of their milk to investigate the effect on milk tolerance
Secondary ID [1] 284363 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FLIP - Flavour for Infants born Preterm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
milk intolerance in preterm infants 291525 0
Condition category
Condition code
Diet and Nutrition 291896 291896 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 291897 291897 0 0
Normal oral and gastrointestinal development and function
Reproductive Health and Childbirth 292552 292552 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group
Infants will be exposed to the smell and taste of milk during tube-feeding. The milk taste will be provided with a cotton wool bud dipped in milk. Additionally, a cotton wool pad with a drop of milk will be place on front of the infant’s nose to provide the milk odor for the duration of the feed. The intervention is continued until the infants start suck feeds.
Intervention code [1] 289092 0
Treatment: Other
Comparator / control treatment
Control group for comparison
Infants in the control group will not be exposed to the smell and taste of milk during tube-feeding.
Control group
Active

Outcomes
Primary outcome [1] 291816 0
Time to full enteral feeds
Timepoint [1] 291816 0
At reaching full enteral feeds
Secondary outcome [1] 307604 0
Weight gain assessed using calibrated digital scales
Timepoint [1] 307604 0
36 weeks corrected gestational age
Secondary outcome [2] 308895 0
Culture proven sepsis
Timepoint [2] 308895 0
36 weeks corrected gestational age

Eligibility
Key inclusion criteria
Preterm infants less than 29 weeks gestational age
Minimum age
No limit
Maximum age
5 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
older than 29 weeks gestation at birth

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)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
7/03/2014
Date of last participant enrolment
Anticipated
1/03/2016
Actual
30/04/2015
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
100
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289006 0
Charities/Societies/Foundations
Name [1] 289006 0
Medical Research Foundation for Women and Babies
Country [1] 289006 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
Mercy Hospital for Women
163 Studley Rd
Heidelberg, Vic 3084
Australia
Country
Australia
Secondary sponsor category [1] 287685 0
None
Name [1] 287685 0
Address [1] 287685 0
Country [1] 287685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290815 0
HREC Mercy Hospital for Women
Ethics committee address [1] 290815 0
Ethics committee country [1] 290815 0
Australia
Date submitted for ethics approval [1] 290815 0
Approval date [1] 290815 0
19/12/2013
Ethics approval number [1] 290815 0
R13/53

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

Contacts
Principal investigator
Name 47378 0
Dr Friederike Beker
Address 47378 0
Mater Mothers' Hospital, Raymond Terrace, South Brisbane, 4101
Country 47378 0
Australia
Phone 47378 0
+61 7 3163 8111
Fax 47378 0
Email 47378 0
[email protected]
Contact person for public queries
Name 47379 0
Friederike Beker
Address 47379 0
Mater Mothers' Hospital, Raymond Terrace, South Brisbane, 4101
Country 47379 0
Australia
Phone 47379 0
+61 7 3163 8111
Fax 47379 0
Email 47379 0
[email protected]
Contact person for scientific queries
Name 47380 0
Friederike Beker
Address 47380 0
Mater Mothers' Hospital, Raymond Terrace, South Brisbane, 4101
Country 47380 0
Australia
Phone 47380 0
+61 7 3163 8111
Fax 47380 0
Email 47380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing may be available on request with the approval of the local governance department.


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.