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Trial registered on ANZCTR


Registration number
ACTRN12617000583347
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
26/04/2017
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of smell and taste to improve nutrition in very preterm babies.
Scientific title
Smell and taste with tube feeding to improve nutrition in very preterm infants: a randomized controlled trial.
Secondary ID [1] 291110 0
n/a
Universal Trial Number (UTN)
U1111-1192-6122
Trial acronym
TASTE trial
Linked study record
This is a follow up to the published pilot trial:
Neonatology. 2016 Dec 1;111(3):260-266. [Epub ahead of print]
Smell and Taste to Improve Nutrition in Very Preterm Infants: A Randomized Controlled Pilot Trial.
Beker F, Opie G, Noble E, Jiang Y, Bloomfield FH.

Health condition
Health condition(s) or problem(s) studied:
prematurity 301937 0
growth failure 301938 0
milk intolerance 301939 0
Condition category
Condition code
Diet and Nutrition 301590 301590 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 302454 302454 0 0
Childbirth and postnatal care
Oral and Gastrointestinal 302455 302455 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
smell and taste of milk (mothers' breast milk, pasteurized donor breast milk or formula, whatever is fed at the time) with tube feeding - with every feed for the duration of the feed
<32 weeks gestation until 32 weeks gestation: cotton bud soaked in milk offered for sucking and drop of milk on cotton pad placed close to the infants nose
>32 weeks gestation until removal of nasogastric tube or discharge: 0.2 ml of milk given orally with a feeding syringe will will be provided
Intervention code [1] 297099 0
Treatment: Other
Comparator / control treatment
Control group: routine care: no smell and taste of milk with tube feeding

Note: infants in both groups are allowed to have breast feeds/cuddles and dummies at any time.
Control group
Active

Outcomes
Primary outcome [1] 300996 0
Weight z-scores at discharge home assessed by calibrated digital scales.
Timepoint [1] 300996 0
Discharge home
Secondary outcome [1] 331381 0
Time (days) to full enteral feeds (120 ml/kg/d for at least 24 hours), assessed by review of feeding records.
Timepoint [1] 331381 0
reaching of full enteral feeds
Secondary outcome [2] 331382 0
Duration of parenteral nutrition (days) total assessed by chart review
Timepoint [2] 331382 0
from admission until discharge from hospital
Secondary outcome [3] 331383 0
Duration of antibiotics (days) total, assessed by review of medical records
Timepoint [3] 331383 0
from admission until discharge from hospital
Secondary outcome [4] 331384 0
Episodes of late onset sepsis, assess by review of medical records.
Timepoint [4] 331384 0
discharge from hospital
Secondary outcome [5] 331387 0
postmenstrual age at discharge home from hospital, assessed by review of medical records.
Timepoint [5] 331387 0
at discharge from hospital
Secondary outcome [6] 334152 0
Duration of parenteral nutrition - first episode, assessed by chart review
Timepoint [6] 334152 0
cessation of parenteral nutrition - first episode.

Eligibility
Key inclusion criteria
< 29 weeks postmenstrual age and/or less than 1250 g birth weight
Minimum age
0 Days
Maximum age
14 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. infants with congenital conditions associated with the digestive system requiring surgery shortly after birth, e.g.: gastroschisis, any malformation requiring a stoma after birth (e.g.: anal atresia), oesophageal atresia.
2. Congenital conditions leading to impaired growth: e.g.: trisomy 21, trisomy 18, salt wasting enteropathy.

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)
serially numbered, sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block design stratified by sex and gestational age (<27 weeks' PMA, >= 27 weeks' PMA) in which twins and triplets will be randomized together.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary outcome: t-test for the significance of the difference between the means of two independent samples. The statistical analysis is based on an intention to treat analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 7442 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 9210 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 15256 0
4101 - South Brisbane
Recruitment postcode(s) [2] 17865 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295551 0
Hospital
Name [1] 295551 0
Mater Research
Address [1] 295551 0
Raymond Terrace
South Brisbane, QLD 4101
Country [1] 295551 0
Australia
Funding source category [2] 295552 0
Other
Name [2] 295552 0
Royal College of Physicians and Paediatricians - Queensland Branch
Address [2] 295552 0
Unit 20, Level 3 Royal Brisbane Place
17 Bowen Bridge Road
Herston Qld 4006
Country [2] 295552 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Limited
Address
Raymond Terrace
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 295144 0
None
Name [1] 295144 0
none
Address [1] 295144 0
Country [1] 295144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296873 0
Mater Research HREC Office
Ethics committee address [1] 296873 0
Raymond Terrace
South Brisbane
QLD 4101
Ethics committee country [1] 296873 0
Australia
Date submitted for ethics approval [1] 296873 0
Approval date [1] 296873 0
11/04/2017
Ethics approval number [1] 296873 0
HREC/16/MHS/112 - AM02
Ethics committee name [2] 298858 0
Royal Women’s Hospital Human Research Ethics Committee
Ethics committee address [2] 298858 0
Royal Women’s Hospital, 20 Flemington Road, Parkville 3052
Ethics committee country [2] 298858 0
Australia
Date submitted for ethics approval [2] 298858 0
23/06/2017
Approval date [2] 298858 0
18/09/2017
Ethics approval number [2] 298858 0
17/21

Summary
Brief summary
Extremely premature infants do not tolerate enteral feeds well and are routinely tube fed. Our pilot trial suggests that regular smell and taste of milk with tube feeds may lead to better milk tolerance in very preterm infants, but interestingly may also increase weight z-scores at discharge, an outcome potentially relatedto better head growth and later neurodevelopmental outcomes.
Trial website
not available
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72290 0
Dr Friederike Beker
Address 72290 0
Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 72290 0
Australia
Phone 72290 0
+61 7 316301955
Fax 72290 0
Email 72290 0
friederike.beker@mater.org.au
Contact person for public queries
Name 72291 0
Dr Friederike Beker
Address 72291 0
Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 72291 0
Australia
Phone 72291 0
+61 7 3163 1955
Fax 72291 0
Email 72291 0
friederike.beker@mater.org.au
Contact person for scientific queries
Name 72292 0
Dr Friederike Beker
Address 72292 0
Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 72292 0
Australia
Phone 72292 0
+61 7 3163 1955
Fax 72292 0
Email 72292 0
friederike.beker@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data can be made available if a data sharing agreement is in place.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
How or where can supporting documents be obtained?
Type [1] 4920 0
Study protocol
Citation [1] 4920 0
Beker F, Macey J, Liley H, et al. The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial. BMJ Open 2019;9:e027805. doi: 10.1136/bmjopen-2018-027805
Link [1] 4920 0
Email [1] 4920 0
Other [1] 4920 0
Attachment [1] 4920 0
Type [2] 4921 0
Statistical analysis plan
Citation [2] 4921 0
Beker F, Macey J, Liley H, et al. The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial. BMJ Open 2019;9:e027805. doi: 10.1136/bmjopen-2018-027805
Link [2] 4921 0
Email [2] 4921 0
Other [2] 4921 0
Attachment [2] 4921 0
Type [3] 4922 0
Informed consent form
Citation [3] 4922 0
Beker F, Macey J, Liley H, et al. The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial. BMJ Open 2019;9:e027805. doi: 10.1136/bmjopen-2018-027805
Link [3] 4922 0
Email [3] 4922 0
Other [3] 4922 0
Attachment [3] 4922 0
Summary results
No Results