ANZCTR - Registration

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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

4/04/2024

Date data sharing statement initially provided

19/09/2019

Date results provided

11/02/2021

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]

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

growth failure

milk intolerance

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

Childbirth and postnatal care

Oral and Gastrointestinal

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]

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]

Weight z-scores at discharge home assessed by calibrated digital scales.

Timepoint [1]

Discharge home

Secondary outcome [1]

Time (days) to full enteral feeds (120 ml/kg/d for at least 24 hours), assessed by review of feeding records.

Timepoint [1]

reaching of full enteral feeds

Secondary outcome [2]

Duration of parenteral nutrition (days) total assessed by chart review

Timepoint [2]

from admission until discharge from hospital

Secondary outcome [3]

Duration of antibiotics (days) total, assessed by review of medical records

Timepoint [3]

from admission until discharge from hospital

Secondary outcome [4]

Episodes of late onset sepsis, assess by review of medical records.

Timepoint [4]

discharge from hospital

Secondary outcome [5]

postmenstrual age at discharge home from hospital, assessed by review of medical records.

Timepoint [5]

at discharge from hospital

Secondary outcome [6]

Duration of parenteral nutrition - first episode, assessed by chart review

Timepoint [6]

cessation of parenteral nutrition - first episode.

Secondary outcome [7]

Data collected from infants assessed in the long-term follow up program at 1 and 2 years corrected age (e.g: anthropometric data, respiratory support, type of feeding, cerebral palsy, level within the Gross Motor Function Classification System, hearing and vision assessments, Bayley III results)

Timepoint [7]

within the first two years corrected age

Secondary outcome [8]

Feeding behaviour
Patients enrolled at the Mater Mothers' Hospital are eligible. Patient data is collected using a paper questionnaire, presented by the research nurse at discharge and at the 2 year follow up appointment

Timepoint [8]

discharge and 2 years corrected age.

Eligibility

Key inclusion criteria

< 29 weeks postmenstrual age and/or less than 1250 g birth weight

Minimum age

0 Days

Maximum age

14 Days

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2017

Actual

8/05/2017

Date of last participant enrolment

Anticipated

31/07/2020

Actual

1/02/2020

Date of last data collection

Anticipated

1/07/2022

Actual

31/10/2022

Sample size

Target

390

Accrual to date

Final

396

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Recruitment hospital [2]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

4101 - South Brisbane

Recruitment postcode(s) [2]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mater Research

Address [1]

Raymond Terrace
South Brisbane, QLD 4101

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Royal College of Physicians and Paediatricians - Queensland Branch

Address [2]

Unit 20, Level 3 Royal Brisbane Place
17 Bowen Bridge Road
Herston Qld 4006

Country [2]

Australia

Primary sponsor type

Hospital

Name

Mater Misericordiae Limited

Address

Raymond Terrace
South Brisbane, QLD 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Research HREC Office

Ethics committee address [1]

Raymond Terrace
South Brisbane
QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/04/2017

Ethics approval number [1]

HREC/16/MHS/112 - AM02

Ethics committee name [2]

Royal Women’s Hospital Human Research Ethics Committee

Ethics committee address [2]

Royal Women’s Hospital, 20 Flemington Road, Parkville 3052

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/06/2017

Approval date [2]

18/09/2017

Ethics approval number [2]

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

Dr Friederike Beker

Address

Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101

Country

Australia

Phone

+61 7 316301955

Fax

[email protected]

Contact person for public queries

Name

Friederike Beker

Address

Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101

Country

Australia

Phone

+61 7 3163 1955

Fax

[email protected]

Contact person for scientific queries

Name

Friederike Beker

Address

Neonatal Critical Care Unit
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
QLD 4101

Country

Australia

Phone

+61 7 3163 1955

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation
4920	Study protocol	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
4921	Statistical analysis plan	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
4922	Informed consent form	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

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): A protocol for a randomised controlled trial.	2019	https://dx.doi.org/10.1136/bmjopen-2018-027805
Embase	Effects on Growth of Smell and Taste of Milk during Tube Feeding of Preterm Infants: A Randomized Clinical Trial.	2021	https://dx.doi.org/10.1001/jamapediatrics.2021.2336
Embase	Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol.	2023	https://dx.doi.org/10.1186/s13063-023-07224-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically