Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000272291
Ethics application status
Approved
Date submitted
12/02/2018
Date registered
22/02/2018
Date last updated
1/12/2020
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SENSE trial: Language Exposure of Preterm Infants in the Neonatal Unit
Scientific title
Sensory Exposure of Neonates in the Single-room Environment (SENSE): A multi-method trial of sound and language exposure in preterm neonates cared for in single-room environments on developmental outcomes up to 2 years.
Secondary ID [1] 294024 0
None
Universal Trial Number (UTN)
U1111-1209-2540
Trial acronym
SENSE
Linked study record
This record is a sub-study of the "SENSE" research project, Phase 1 observed light exposure, Phase 2 observed sound exposure and Phase 3 is language exposure in the neonatal unit.

Best, Kobi, Bogossian, Fiona and New, Karen (2017) Sensory exposure of neonates single-room environments (SENSE): an observational study of light. Archives of Disease in Childhood Fetal and Neonatal Edition, . doi:10.1136/archdischild-2017-312977

Health condition
Health condition(s) or problem(s) studied:
Neurodevelopment in preterm infants 306554 0
Language development in preterm infants 306555 0
Motor development in preterm infants 306556 0
Condition category
Condition code
Reproductive Health and Childbirth 305652 305652 0 0
Childbirth and postnatal care
Neurological 305718 305718 0 0
Studies of the normal brain and nervous system
Mental Health 305719 305719 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 305720 305720 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered by microspeaker. The intervention will take place in the single-room designed Neonatal Intensive Care Unit and Special Care Nursery of the Gold Coast University Hospital. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a low-dose of 600 words/hour within a developmental appropriate decibel range. Each group will receive the exposure over one hour, three times daily. The mother of each enrolled participant will be asked to read a short story selected by the research team, for ten minutes. This recording will be processed using a software program to convert the 10 minute reading into an mp3 recording which will automatically play the desired 'dose' throughout the day at three 1-hour intervals. A team of research nurses enrolled in the study will be responsible for pressing play on the recording in the morning.
Intervention code [1] 300298 0
Other interventions
Comparator / control treatment
The control group will receive a placebo level of language exposure of 600 words/hour within a developmental appropriate decibel range. The control group will receive the exposure over one hour, three times daily. The mother of each enrolled participant will be asked to read a short story selected by the research team, for ten minutes. This recording will be processed using a software program to convert the 10 minute reading into an mp3 recording which will automatically play the desired 'dose' throughout the day at three 1-hour intervals. A team of research nurses enrolled in the study will be responsible for pressing play on the recording in the morning.
Control group
Dose comparison

Outcomes
Primary outcome [1] 304764 0
Language development at 24 months corrected age determined by the Bayley Scales of Infant Development - IV
Timepoint [1] 304764 0
24 months corrected age
Secondary outcome [1] 343387 0
Short-term outcomes [Birth to discharge]
Time to full enteral feeds
Timepoint [1] 343387 0
Birth until discharge from the Newborn Care Unit
Secondary outcome [2] 343388 0
Short-term outcomes [Birth to discharge]
Time to full oral feeds,
Timepoint [2] 343388 0
Birth until discharge from the Newborn Care Unit
Secondary outcome [3] 343389 0
Short-term outcomes [Birth to discharge]
Velocity of weight gain,
Timepoint [3] 343389 0
Birth until discharge from the Newborn Care Unit
Secondary outcome [4] 343390 0
Short-term outcomes [Birth to discharge]
Weight at discharge
Timepoint [4] 343390 0
Birth until discharge from the Newborn Care Unit
Secondary outcome [5] 343391 0
Short-term outcomes [Birth to discharge]
Length of stay.
Timepoint [5] 343391 0
Birth until discharge from the Newborn Care Unit
Secondary outcome [6] 343392 0
Intermediate outcomes [3 months]
Rossetti Infant-Toddler Language Scale (3 months)
The Rossetti Infant-Toddler Language Scale measures communication and interaction in infant at 3 months of age. It is used as a screening tool to identify infants at risk. The instrument assesses six components: Interaction-Attachment, Pragmatics, Gesture, Play, Language Comprehension, and Language Expression.
Timepoint [6] 343392 0
3 months corrected age
Secondary outcome [7] 343393 0
Intermediate outcomes [3 months]
Prechtl general movements assessment (3 months)
The Prechtl assessment is used to assess absent or abnormal general movements of infants at 3 months of age. The assessment tool is widely used and there is substantial evidence that this method has good inter- and intra-observer agreement. The tool has been shown to be a good predictor of neurological outcome.
Timepoint [7] 343393 0
3 months corrected age
Secondary outcome [8] 343394 0
Intermediate outcomes [3, 6, 12 months]
Hammersmith Infant Neurological Examination [HINE] (3, 6 & 12 months)
HINE is a neurological examination that can be used to assess neurological ability of infants from 2-24 months of age. Twenty-six elements are included across five separate domains, which are combined to create a global score. The tool has been widely used in both term and preterm infants and has shown good predictability of Cerebral Palsy in scores less than 57 at 3 months of age (sensitivity 96% and specificity 87%).
Timepoint [8] 343394 0
3, 6 & 12 months corrected age
Secondary outcome [9] 343395 0
Intermediate outcomes [6, 12 months]
Communication & Symbolic Behaviour Scales Developmental Profile [CSBS DP] (6 & 12 months)
Is a routine screening tool which is used to assess 6 main elements including: emotion and eye gaze, communication, gestures, infant sounds, infant words, and understanding. The results produce a dichotomous variable of either 'concern' or 'no concern' which is then used for early referral to the GCUH multi-disciplinary clinic for further follow-up.
Timepoint [9] 343395 0
6 & 12 months corrected age

Eligibility
Key inclusion criteria
All preterm infants born at <30 weeks gestation or <1000g who are admitted to the NICU at Gold Coast University Hospital, with at least one consenting parent and mother who is willing to provide a recording of maternal voice in infant-directed speech.
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant neurological conditions (e.g., severe IVH). Preterm infants so critically unwell that they are not expected to survive.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (block randomization using the ralloc command of Stata) to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 14 in each group was calculated using a power of 0.8 and a significance level of 0.05 for detecting an effect size of 1 standard deviation (SD) difference (15 points) on Bayley III Scales of Infant Development by means of a two-sample t-test. As it is likely that twins will be enrolled, the sample size estimate will be required to be inflated by a factor of 1+(m-1)r (the design effect) where m is the mean number of babies per mother and r is the intraclass correlation coefficient with respect to the outcome of interest. From previous studies (eg Gray PH, Pers. Comm.) we estimated m=1.19 and r to range from 0.58 to 0.69 for Bayley IV Cognitive, Language, and Motor scores thus, using r=0.69, giving an adjusted total sample size of 28×1.1311=32. As this is a longitudinal study with a two year follow up, an allowance of an attrition rate of 30% has further been calculated into the sample size. That is, sample size = 32/(1-0.3)=46, or 23 per group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/03/2018
Actual
3/08/2018
Date of last participant enrolment
Anticipated
3/08/2019
Actual
2/01/2020
Date of last data collection
Anticipated
7/04/2022
Actual
Sample size
Target
46
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10002 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 19328 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 298646 0
Government body
Name [1] 298646 0
National Health and Medical Research Council
Country [1] 298646 0
Australia
Funding source category [2] 298648 0
University
Name [2] 298648 0
The University of Queensland
Country [2] 298648 0
Australia
Funding source category [3] 298649 0
Hospital
Name [3] 298649 0
Gold Coast University Hospital Private Practice Trust
Country [3] 298649 0
Australia
Funding source category [4] 298650 0
Government body
Name [4] 298650 0
Queensland Health and Medical Research Scholarship
Country [4] 298650 0
Australia
Funding source category [5] 298651 0
Charities/Societies/Foundations
Name [5] 298651 0
Australian College of Neonatal Nurses
Country [5] 298651 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia Qld 4072
Australia
Country
Australia
Secondary sponsor category [1] 297818 0
Hospital
Name [1] 297818 0
Gold Coast University Hospital
Address [1] 297818 0
Gold Coast University Hospital
1 Hospital Boulevard,
Southport, QLD, 4215
Country [1] 297818 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299605 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 299605 0
Ethics committee country [1] 299605 0
Australia
Date submitted for ethics approval [1] 299605 0
17/11/2017
Approval date [1] 299605 0
02/02/2018
Ethics approval number [1] 299605 0
HREC/17/QGC/330

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

Contacts
Principal investigator
Name 81002 0
Mrs Kobi Best
Address 81002 0
C/O Newborn Care Unit
Gold Coast University Hospital
1 Hospital Boulevard,
Southport, 4215, QLD
Country 81002 0
Australia
Phone 81002 0
+61402759584
Fax 81002 0
Email 81002 0
[email protected]
Contact person for public queries
Name 81003 0
Kobi Best
Address 81003 0
C/O Newborn Care Unit
Gold Coast University Hospital
1 Hospital Boulevard,
Southport, 4215, QLD
Country 81003 0
Australia
Phone 81003 0
+61402759584
Fax 81003 0
Email 81003 0
[email protected]
Contact person for scientific queries
Name 81004 0
Kobi Best
Address 81004 0
C/O Newborn Care Unit
Gold Coast University Hospital
1 Hospital Boulevard,
Southport, 4215, QLD
Country 81004 0
Australia
Phone 81004 0
+61402759584
Fax 81004 0
Email 81004 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
No further data to share


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.