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Trial registered on ANZCTR


Registration number
ACTRN12617001169336
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
9/08/2017
Date last updated
9/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of teats to support Successful transition to Oral Feeding (SOFTT) in preterm and fragile infants (SOFTT).
Scientific title
A comparison of two Teats to support Successful transition to Oral Feeding in preterm and fragile Infants (SOFTT).
Secondary ID [1] 291901 0
Successful Oral Feeding Teat Trial (SOFTT)
Universal Trial Number (UTN)
Trial acronym
SOFTT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Prematurity 303199 0
Transition to oral feeding 303201 0
Bottle feeding in preterm infants 303202 0
Condition category
Condition code
Reproductive Health and Childbirth 302637 302637 0 0
Complications of newborn
Diet and Nutrition 303646 303646 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sepal Teat [Sepal Infant Feeding System]

The SOFTT will use a randomized controlled cross-over design to investigate infant feeding performance, and is a single centre trial. As part of the trial design, all infants will receive bottle feeds from both types of teat. The teat allocation envelope is opened at the beside immediately prior to the commencement of the first bottle feeding trial by the infant’s allocated nurse, in the presence of the parent (if in attendance) or other health professional (if parent not in attendance). The teat allocation is recorded on the infant’s SOFTT-BF1 form.

Once parent/guardian written signed consent is obtained, the consent form will be given to the nursing team leader or research officer and the infant will be allocated a participant number. The infant’s feeding schedule will then be reviewed and the date/time for the first bottle feeding trial (BF1) identified. Baseline data on the infant’s ‘SOFTT-Demographic’ data collection form will be completed and then given to the nursing team leader or research officer.

BF1: The teat allocation envelope is opened at the bedside immediately prior to the commencement of the first bottle feeding trial by the infant’s treating nurse, in the presence of the parent (if in attendance) or other health professional (if parent not in attendance). The teat allocation (Teat 1 – either Sepal or Medela) will then be used for the first trial. The infant’s treating nurse will observe and score the infant’s feeding readiness cues using a feeding readiness scale, and if appropriate, proceed with the bottle feeding trial using Teat 1. Either the infant’s nurse or parent will feed the infant, however the nurse will observe infant feeding performance and infant cues throughout the trial. The length of the feed will be indicated by infant tolerance and terminated according to infant cues of satiation or feeding intolerance as per standard practice. The nurse will complete the ‘SOFTT-BF1’ data collection form at the end of the feed and give to the nursing team leader or research officer.

BF2: On the following day (or next bottle feed, whichever is sooner), the second bottle feed (BF2) will be conducted using the other teat brand (Teat 2 – Medela or Sepal). Again, the infant’s treating nurse will observe the infant’s feeding readiness cues, and if appropriate, proceed with the bottle feeding trial using Teat 2. Either the infant’s nurse or parent will feed the infant, however the nurse will observe infant feeding performance and infant cues throughout the trial. The length of the feed will be indicated by infant tolerance and terminated according to infant cues of satiation or feeding intolerance. The nurse will complete the ‘SOFTT-BF2’ data collection form at the end of the feed and give to the nursing team leader or research officer. Following completion of the infant’s participation in the study, the parents/nursing staff will be free to choose their preferred teat for the individual infant for further bottle feeds during their hospital stay.

All nursing staff who will be feeding infants for the “Successful Oral Feeding Teat Trial” will be required to attend an education session about the study, study procedures and how to complete study forms including recording teat information and observing infant cues (specific infant feeding readiness cues, infant state cues, suck-swallow-breath coordination, feeding tolerance cues, feeding intolerance cues, and satiation cues). As part of the evaluation of this education, nursing staff will be asked to participate in nested quality activity study to evaluate the effect of the training and use of SOFTT study data collection forms on their understanding and observation of infant cues to inform their infant feeding practices.


Intervention code [1] 298022 0
Treatment: Devices
Comparator / control treatment
Standard Ward Teat: Medela Teat

The study is a cross over trial as described in the intervention box. The Medela Teat is the 'control' arm as this is the current standard teat used in the Newborn Care Unit.
Control group
Active

Outcomes
Primary outcome [1] 302051 0
Oral Feeding Readiness Score [1-5]
Timepoint [1] 302051 0
At the beginning of each bottle feed [BF1 & BF2]
Primary outcome [2] 302052 0
Oral Feeding Quality Scale Score [0-17]
[Includes Attachment, Alertness, SSB coordination, Fluid Loss, Work of Breathing, Clinical Signs of Aspiration/Swallowing Dysfunction, Infant Communication cues & Volume Percentage]
Timepoint [2] 302052 0
At the end of the feed for each bottle feed [BF1 & BF2]
Secondary outcome [1] 334622 0
Volume taken per bottle feed: determined by recording the amount in the bottle at the beginning of the feed and the amount in the bottle at the end of the feed and determining the difference to record as the amount taken. Any spillage must be recorded.
Timepoint [1] 334622 0
At the beginning & end of each bottle feed.
Secondary outcome [2] 334623 0
Infant state [1-6] Including: "Quiet Sleep, Active Sleep, Drowsy, Quiet Alert, Active Alert & Crying/distress" described in the "Keys to Caregiving" Study Guide, Revised edition, NCAST Programs, University of Washington, Seattle Washington (c) 1999.
Timepoint [2] 334623 0
Before, during (approximately 10 minutes into the feed) and after each bottle feed [BF1 & BF2]
Secondary outcome [3] 334624 0
Infant Cues [Hunger & Satiation Cues] assessed by visualising the child and marking against the SOFTT B1 & B2 data collection forms [item 4 - Hunger cues & item 10 - Satiation cues].
Timepoint [3] 334624 0
Infant Cues will be evaluated before and after B1 & B2 feeds.
Secondary outcome [4] 337708 0
Nursing staff awareness will be evaluated on a staff questionnaire before the commencement of trial involvement & at the conclusion of the trial as part of the quality activity project nested in this trial.
Timepoint [4] 337708 0
Assessed Pre-trial: before SOFTT study commences and post trial completion.

Eligibility
Key inclusion criteria
Infants may include any infant born preterm (<37 weeks gestational age) or term age who are medically stable (including stable cardiorespiratory function), demonstrate feeding readiness cues and are cleared for and parental consent obtained for bottle feeding trials. Preterm infants must be greater than or equal to 34 weeks corrected gestational age, have clearance for oral bottle feeds by their treating physician, demonstrate tolerance of full enteral feeds, tolerance of skin-to-skin contact, have the ability to sustain non-nutritive sucking on a pacifier or expressed breast, and have the ability to transition to an alert state. Term infants must have clearance for oral bottle feeds by a medical officer, tolerance of skin-to-skin contact, have the ability to sustain non-nutritive sucking on a pacifier or expressed breast, have the ability to transition to an alert state and demonstrate ‘feeding readiness cues’. Infants will not be excluded if they are on low flow oxygen via nasal cannula, however they must have stable cardiorespiratory function whilst being supplemented.
Minimum age
No limit
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Term or preterm infants who are exclusively breastfed
2. Preterm infants <34 weeks corrected gestational age
3. Infants who do not demonstrate feeding readiness signs
4. Congenital anomalies affecting aerodigestive anatomy predisposing infants to oropharyngeal aspiration (e.g. choanal atresia, tracheoesophageal fistula, laryngeal cleft, oesophageal atresia, tumour)
5. Congenital anomalies impacting on sucking ability (e.g. cleft palate)
6. Absent swallow reflex or high risk of aspiration
7. Infants on high flow nasal cannula therapy
8. Children under the care of the department of child safety

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)
Allocation concealment will be maintained with group allocation (Sepal teat vs Medela teat) being concealed in sequentially numbered, opaque envelopes until after consent and baseline information has been obtained. The teat allocation envelope is opened at the beside immediately prior to the commencement of the first bottle feeding trial by the infant’s allocated nurse, in the presence of the parent (if in attendance) or other health professional (if parent not in attendance).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated simple randomization list will be produced by the study statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be summarized using mean (standard deviation) or median (interquartile range) for continuous data, depending on distribution, and as frequency (percentage) for categorical data. Continuous outcomes will be analysed using either a paired t-test (parametric analysis) or Wilcoxon signed-rank test (nonparametric analysis) as appropriate. Binary outcomes will be analysed using McNemar’s test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7975 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 15949 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 296408 0
Hospital
Name [1] 296408 0
Gold Coast University Hospital
Country [1] 296408 0
Australia
Funding source category [2] 296409 0
University
Name [2] 296409 0
Griffith University
Country [2] 296409 0
Australia
Primary sponsor type
Individual
Name
Angie Canning
Address
Gold Coast University Hospital, Newborn Care Unit, C Block, Level 3, 1 Hospital Boulevard, Southport, QLD 4215 Australia
Country
Australia
Secondary sponsor category [1] 295347 0
Individual
Name [1] 295347 0
Rachael Oorloff
Address [1] 295347 0
Gold Coast University Hospital, Newborn Care Unit, C Block, Level 3, 1 Hospital Boulevard, Southport QLD 4215 Australia
Country [1] 295347 0
Australia
Secondary sponsor category [2] 295349 0
Individual
Name [2] 295349 0
Dr Kelly Weir
Address [2] 295349 0
Menzies Health Institute Queensland, (School of Allied Health Sciences), Griffith University, Gold Coast Campus, G40_2.69, Southport QLD 4222
Country [2] 295349 0
Australia
Secondary sponsor category [3] 295350 0
Individual
Name [3] 295350 0
Dr Timothy Hong
Address [3] 295350 0
Newborn Care Unit,
C Block, Level 3, Gold Coast University Hospital,
1 Hospital Boulevard, Southport QLD 4215
Country [3] 295350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297633 0
Gold Coast Hospital & Health Service HREC
Ethics committee address [1] 297633 0
Research Directorate
Level 2, Pathology & Education Building
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 297633 0
Australia
Date submitted for ethics approval [1] 297633 0
15/03/2017
Approval date [1] 297633 0
18/04/2017
Ethics approval number [1] 297633 0
HRECT/17/QCC/71

Summary
Brief summary
The “Successful Oral Feeding Teat Trial (SOFTT)” will investigate infant feeding performance on two brands of teats (Sepal vs Medela) to evaluate if infants have better feeding performance, suck-swallow-breathe coordination and quality of feeding (including infant cues of tolerance and intolerance) on a specific brand of teat. This study will determine if a new range of teats ‘Sepal Infant Feeding System” designed by speech pathologists and dietitians at Royal Children’s Hospital in Melbourne improves infant feeding performance and quality of feeds compared to the teats currently used in the Newborn Care Nursery. This study incorporates a randomised crossover design, where infants suitable to commence oral bottle feeds will be randomised initially to either the Sepal or Medella teat and have their oral feeding performance observed on two consecutive bottle feeds (BF1 - Teat 1; BF2 - Teat 2) by their treating nurse. This information will provide novel data for the international literature about the effects of Sepal teats in fragile infants admitted to a Newborn Care Unit for issues including prematurity and inform future purchasing and supply of teats for Gold Coast University Hospital. Additionally, we will investigate whether participation in education sessions on cue-based feeding practices and feeding infants in the SOFTT trial will increase nursing staff awareness and reporting of feeding quality and infant cues in the electronic medical record. This will facilitate research translation and uptake about the benefits of cue-based care to practice in the Newborn Care Unit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74658 0
Ms Angie Canning
Address 74658 0
Senior Paediatric Speech Pathologist
Newborn Care Unit
C Block, Level 3, Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 74658 0
Australia
Phone 74658 0
+617 5687 3176
Fax 74658 0
Email 74658 0
Angie.Canning@health.qld.gov.au
Contact person for public queries
Name 74659 0
Ms Rachael Oorloff
Address 74659 0
Senior Paediatric Speech Pathologist
Newborn Care Unit
C Block, Level 3, Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 74659 0
Australia
Phone 74659 0
+617 5687 3176
Fax 74659 0
Email 74659 0
Rachael.Oorloff@health.qld.gov.au
Contact person for scientific queries
Name 74660 0
Dr Kelly Weir
Address 74660 0
Menzies Health Institute Queensland
Griffith Health Building, G40-2.69
Gold Coast Campus
Southport QLD 4222
Country 74660 0
Australia
Phone 74660 0
+617 5552 9595
Fax 74660 0
Email 74660 0
kelly.weir@griffith.edu.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

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