Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000371291
Ethics application status
Approved
Date submitted
22/02/2018
Date registered
12/03/2018
Date last updated
27/10/2023
Date data sharing statement initially provided
14/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Improvement through early Restoration of cirCADian rhythms in very preterm Infants via Environmental Modification: The CIRCA DIEM Study
Scientific title
Cognitive Improvement at 2 years corrected postnatal age through early Restoration of cirCADian rhythms in very preterm Infants via Environmental Modification from birth until discharge home: The CIRCA DIEM study
Secondary ID [1] 294029 0
None
Universal Trial Number (UTN)
U1111-1209-2683
Trial acronym
CIRCA DIEM
Linked study record
ACTRN12617000346370 is an observational study that we commenced in 2017 to document current status regarding development of circadian rhythms in the contemporary neonatal intensive care unit. There was no intervention in ACTRN12617000346370. The observational data from ACTRN12617000346370 have informed the development of the protocol for this trial.

Health condition
Health condition(s) or problem(s) studied:
Prematurity 306560 0
Circadian rhythm 306561 0
Neurodevelopment 306562 0
Condition category
Condition code
Reproductive Health and Childbirth 305655 305655 0 0
Complications of newborn
Neurological 305657 305657 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Very preterm infants (<32 w gestation) will be randomised to either standard environmental care (control) or a cycled environment (light and noise) from birth until discharge. The intervention group will receive cycled environmental light and noise to simulate day/night-time environments using a pragmatic 14 hour day (6 am – 8 pm), 10 hour night (8 pm – 6 am) cycle. Daytime intervention will include exposure to light including removal of cot-covers if present, to achieve lighting within the range of 300-600 lux, whilst avoiding direct bright light to the infant’s eyes. Nocturnal intervention will include repositioning of cot-covers, application of light-occlusive eye-masks; and silicone ear-plugs. Eye-masks and ear-plugs will remain in position during any medical procedures or overnight cares unless removal is necessary for medical reasons. Similar cycling of cot-blankets in combination with cycled light was used previously in a small trial without adverse effects. Hand-held light meters will be used by nursing staff to check light levels to ensure daylight lux targets are achieved and maintained (intervention group) or level of ambient lighting recorded (control group). Lux/noise levels will be documented for full days at Day 7, 14, 28 and 56 (if applicable).

Eye-masks will continue to be used for phototherapy and ear protection for high-frequency ventilation as per normal nursery protocols (normally short-term). Respiratory stimulants (e.g. caffeine) will be regulated to 8 am dosing for all infants, when prescribed, to avoid pharmacologic confounding on circadian rhythm development. Similarly, if postnatal glucocorticoids are prescribed for severe lung disease, they will be given at 6 am/6 pm to reduce nocturnal disruption.

Eye-masks are already used in Australian NICUs as short-term protection from phototherapy light. Similarly, many units use noise protection (ear muffs) to protect the infant from noisy ventilators (e.g. high-frequency oscillators). Silicone ear plugs are more effective at reducing noise than the routine ear muffs used in many neonatal units. The interventions (eye masks and silicone ear plugs) are medically safe for neonates and acceptable to NICU staff. Standardised eye masks and silicone earplugs will be supplied, and applied during each period by the nurse caring for the infant.

Protocol adherence to the intervention will be monitored by inspection of hospital and clinical record form logs, direct observation by trials staff, and auditing of light and sound records.

NICU nursing staff will receive training to demonstrate the correct application of both the eye-masks and the ear-plugs.

Some infants in the CIRCA DIEM study will be involved in substudies that aim to explore underlying mechanisms and additional outcomes related to the intervention.
a) the Biological substudy aims to understand if the study intervention (cycled light and noise) is effective in creating a circadian rhythm in salivary hormones (cortisol and melatonin) and in sleep and activity patterns. Infants are eligible for the Biological substudy if they are enrolled in the parent CIRCA DIEM study, were recruited to the study at King Edward Memorial Hospital, and informed parental assent was provided for substudy participation. Enrolled infants have saliva swabs collected at 4-6 timepoints throughout the day at baseline, 7 d, 14 d, 28 d, 56 d (if < 28 w gestation) and at 36 w postmenstrual age (PMA). Sleep activity behaviours are obtained at the same timepoints with an actiwatch attached to one of their lower limbs.
b) the MRI substudy will be conducted in those infants who have a routine MRI performed around the expected delivery date. There are no additional procedures for sub-study participants other than parents will need to provide informed consent for the MRI images to be examined by experienced trial investigators.
c) the Sleep substudy will evaluate sleep behaviours of CIRCA DIEM study babies and those of their primary caregiver prior to hospital discharge and at 2 months and 6 months following discharge home. This substudy is only performed in those infants recruited in West Australian hospitals. Sleep diaries are completed for infant and primary caregiver and sleep/activity data obtained from actiwatch placed around the limbs of infant and parent. Saliva is also collected from the babies (morning and night) to ascertain if their sleep behaviours align with a circadian rhythm in salivary melatonin.
d) The Social Communication Substudy will explore whether there is an impact of cycled light and noise during hospitalisation on risk for developing Autism Spectrum Disorder. Infants are eligible for the substudy if they are identified as at risk for a behavioural disorder on the CSBS survey that all CIRCA DIEM study infants are asked to complete at 22 months, and their parents provide informed assent to their participation in the substudy. Infants enrolled in the Social Communication Substudy will have an additional assessment (The Autism Diagnostic Observation Schedule - Toddler Module (ADOS-T)) performed at approximately 2 years corrected postnatal age.
Intervention code [1] 300300 0
Treatment: Other
Comparator / control treatment
The control treatment will be routine care with no individual environmental modification.
Control group
Active

Outcomes
Primary outcome [1] 304765 0
Mean difference in cognitive score on Bayley Scales of Infant Development (BSID) - 4th Edition
Timepoint [1] 304765 0
2 years corrected postnatal age (cPNA)
Secondary outcome [1] 343077 0
Survival
Timepoint [1] 343077 0
36 weeks postmenstrual age and 2 years corrected postnatal age
Secondary outcome [2] 343504 0
Language composite subscore on the Bayley Scales of Infant Develpment (BSID)-4th Edition.
The change was approved in v1.08 of the protocol on the 22/09/20 after recruitment of 120 participants but prior to commencement of any of the 2 year follow-up Bayley assessments.
Timepoint [2] 343504 0
2 years corrected postnatal age.
Secondary outcome [3] 343505 0
Proportion of infants > 1 SD and > 2 SD below the mean for the primary Bayley Scales of Infant Develpment (BSID)-4th Edition cognitive subscore outcome
Timepoint [3] 343505 0
2 years corrected postnatal age
Secondary outcome [4] 343506 0
Neurobehaviour using Infant Toddler Social-Emotional Assessment (ITSEA) score for comprehensive assessment of social and emotional development.
Timepoint [4] 343506 0
22 months corrected postnatal age
Secondary outcome [5] 343508 0
Total average time spent asleep per 24 hours for the infant determined from actiwatch recording of sleep behaviour.
Timepoint [5] 343508 0
36 weeks postmenstrual age, 2 months corrected postnatal and age 6 months corrected postnatal age
Secondary outcome [6] 343509 0
Prechtl General Movements Assessment
Timepoint [6] 343509 0
36 weeks; postmenstrual age (PMA), 3 months corrected postnatal age and 3.5 months corrected postnatal age.
Secondary outcome [7] 343510 0
Total Score on the Ages & Stages Questionnaire 3 (ASQ-3):
Timepoint [7] 343510 0
2, 6, 12 and 24 months corrected postnatal age.
Secondary outcome [8] 343511 0
Weight gain in gram per day for the first 28 d of life (assessed from prospectively recorded entries on clinical record forms, and completion of missing data from review of daily medical records )
Timepoint [8] 343511 0
28 days of life
Secondary outcome [9] 343513 0
Grade III or Grade IV intraventricular haemorrhage (Volpe 2008) (assessed by prospective data entry on clinical record forms from radiologists reports of standard cranial ultrasound reports and completion of missing data from review of medical records as required)
Timepoint [9] 343513 0
Day 7 and day 28 brain ultrasound scans
Secondary outcome [10] 343514 0
Periventricular leukomalacia (Volpe 2008) (assessed by prospective data entry on medical record forms from radiologist review of standard cranial ultrasound examinations, and completion of missing data through review of medical records as required).
Timepoint [10] 343514 0
Day 7 and 28 of age brain ultrasound scans
Secondary outcome [11] 343516 0
Incidence of bronchopulmonary dysplasia (28 d of oxygen supplementation)

The presence of bronchopulmonary dysplasia will be defined as requirement for any oxygen supplementation for at least part of a day on at least 28 days after birth as noted on hourly written observations, represented as a binary outcome (yes/no).
Timepoint [11] 343516 0
36 weeks' postmenstrual age
Secondary outcome [12] 343519 0
Severity of bronchopulmonary dysplasia assessed prospectively using Shift test / Modified Walsh Oxygen Reduction Air Trial as per ANZNN protocol (http://anznn.net/Portals/0/DataDictionaries/ANZNN_Shift_Test_protocol_template.pdf accessed on 12/03/2017)
Timepoint [12] 343519 0
36 weeks' postmenstrual age
Secondary outcome [13] 343520 0
number of confirmed episodes of sepsis defined as a positive blood culture
Timepoint [13] 343520 0
36 weeks' postmenstrual age
Secondary outcome [14] 343521 0
duration of oxygen supplementation defined as number of days on which at least 1 hour of supplemental oxygen was required (where supplemental oxygen is a requirement for more than atmospheric oxygen content of 20.8 %), as determined from the daily monitoring sheets or (when available) downloaded electronic records of delivered fractional inspired oxygen concentration.
Timepoint [14] 343521 0
2 years' corrected postnatal age
Secondary outcome [15] 343522 0
duration of initial hospitalisation (until discharge home) determined from hospital records of birth date and discharge home date.
Timepoint [15] 343522 0
3 months corrected postnatal age
Secondary outcome [16] 343523 0
Duration of mechanical ventilation (defined as the duration in hoursof requirement for mechanical respiratory support delivered to the lung via an endotracheal tube) determined from hospital records.
Timepoint [16] 343523 0
3 months corrected postnatal age
Secondary outcome [17] 343524 0
duration (in hours) of any mechanical respiratory support (as recorded in hourly nursing records and where mechanical respiratory support is defined as any one of the following: mechanical ventilation via an endotracheal tube, continuous positive airway pressure or humidified high flow)
Timepoint [17] 343524 0
3 months corrected postnatal age
Secondary outcome [18] 343525 0
postmenstrual age at discharge home from initial hospitalisation as determined from hospital records
Timepoint [18] 343525 0
discharge to home
Secondary outcome [19] 343528 0
Total average time spent asleep per 24 hours for the primary caregiver
Timepoint [19] 343528 0
Parental actimeter measurements are obtained when their infant reaches 2 months corrected postnatal and age 6 months corrected postnatal age..
Secondary outcome [20] 343529 0
Mean Edinburgh Postnatal Depression Scale (EPDS) score for primary carer
Timepoint [20] 343529 0
36 weeks postmenstrual age, 2, 6 and 12 months corrected postnatal age.
Secondary outcome [21] 343530 0
Mean parental depression score as measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Timepoint [21] 343530 0
2 years' corrected postnatal age
Secondary outcome [22] 343531 0
Mean (composite) score for the Generalised Anxiety Disorder-7 (GAD-7) for primary carer
Timepoint [22] 343531 0
Term then 2, 6, 12 and 24 months corrected postnatal age
Secondary outcome [23] 343532 0
Maternal Postnatal Attachment Scale
Timepoint [23] 343532 0
Term then 2, 6, and 12 months corrected postnatal age
Secondary outcome [24] 343533 0
Diagnosis of necrotizing enterocolitis (NEC) using Bell’s criteria 2a or more. (Bell 1978)
Timepoint [24] 343533 0
Home discharge
Secondary outcome [25] 343534 0
Number of infants discharged with home oxygen (assessed by prospective data collection and entry on clinical record form at discharge, and by retrospective review of clinical records for missing data.
Timepoint [25] 343534 0
Discharge to home
Secondary outcome [26] 343535 0
Use of postnatal steroids for BPD before discharge to home (assessed by prospective data collection in clinical record forms and infill of missing data from review of medical records)
Timepoint [26] 343535 0
Home discharge or transfer to other hospital
Secondary outcome [27] 343882 0
Motor composite subscore on the Bayley Scales of Infant Develpment (BSID)-4th Edition
Timepoint [27] 343882 0
2 years' corrected postnatal age.
Secondary outcome [28] 343883 0
Social-emotional subscore on Bayley Scales of Infant Develpment (BSID)-4th Edition
Timepoint [28] 343883 0
2 years' corrected postnatal age
Secondary outcome [29] 343884 0
Weight z score
Timepoint [29] 343884 0
36 weeks postmenstrual age,
2 months corrected postnatal age
6 months corrected postnatal age
1 year corrected postnatal age
2 years corrected postnatal age
Secondary outcome [30] 343885 0
Height Z score
Timepoint [30] 343885 0
36 weeks postmenstrual age,
2 months corrected postnatal age
6 months corrected postnatal age
1 year corrected postnatal age
2 years corrected postnatal age
Secondary outcome [31] 343886 0
Body mass index z score
Timepoint [31] 343886 0
36 weeks postmenstrual age,
2 months corrected postnatal age
6 months corrected postnatal age
1 year corrected postnatal age
2 years corrected postnatal age
Secondary outcome [32] 343887 0
Fat free mass using measure of bioelectrical impedance
Timepoint [32] 343887 0
2 years' corrected postnatal age
Secondary outcome [33] 343888 0
Time to onset of circadian rhythms (salivary hormones - melatonin and cortisol) and onset of correct expression in circadian clock genes (BMAL 1, Per-2, Reverb-alpha): This is a composite outcome'
Timepoint [33] 343888 0
study entry, 7 days, 14 days, 28 days, 56 days (if still inpatient) 84 days (if still inpatient) 112 days (if still inpatient) 36 weeks postmenstrual age
Secondary outcome [34] 343889 0
Communication subscore on the ages and stages questionnaire
Timepoint [34] 343889 0
2, 6, 12 and 24 months corrected postnatal age
Secondary outcome [35] 343891 0
Composite motor subscore on the Ages and Stages questionnaire: (gross motor and fine motor).
Timepoint [35] 343891 0
Timepoints of 2, 6, 12 and 24 months corrected postnatal age
Secondary outcome [36] 343892 0
Problem solving subscore on the Ages and Stages questionnaire
Timepoint [36] 343892 0
2, 6, 12 and 24 months corrected postnatal age
Secondary outcome [37] 343893 0
Personal-social subscore on the Ages & Stages questionnaire
Timepoint [37] 343893 0
2, 6, 12 and 24 months corrected postnatal age
Secondary outcome [38] 344141 0
Cost savings
Short term net savings of healthcare will be estimated by comparing the length of stay with the costs of the intervention. The intervention cost will be assessed by prospective resource unit tracking including materials and time required for application/removal of eye masks and noise protection. Resources will be costed using standard sources.
Cost savings to 2 years will be ascertained by comparison of all prospectively monitored health resource use to 2 years cPNA: Resource use will include hospital readmissions, general practitioner and specialist appointments, and any other health resources. Cost effectiveness will compare costs with measured clinical outcomes. Projected long-term savings will be estimated using the Bayley III outcomes at 2 years corrected age to project long-term cost-benefits to society occuring via increased professional opportunities, and increased contribution to the wider economy. Economic evaluations will be consistent with established economic evaluation methods.
Timepoint [38] 344141 0
discharge home
2 years corrected postnatal age
Secondary outcome [39] 428221 0
Score on the Toddler Module of the Autism Diagnostic Observation Schedule - Second Edition (ADOS-2)
Timepoint [39] 428221 0
24 months corrected postnatal age
Secondary outcome [40] 428222 0
Global abnormality score derived from metrics obtained from T1- and T2-weighted magnetic resonance images from the infant at near term equivalent.
Timepoint [40] 428222 0
Near term equivalent

Eligibility
Key inclusion criteria
• Are born at < 32 weeks postmenstrual age by best obstetric estimate (inborn or outborn)
• Have initial care at a perinatal centre where routine care does not include individual environmental light/noise cycling
• Have informed parental consent to trial participation, obtained either prior to or after birth. (Consent will be obtained either prior to or after birth, using a specific, parent advisory panel and ethics committee approved information and consent form)
Minimum age
0 Hours
Maximum age
168 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Update
• Have a congenital neurodevelopmental abnormality
• Are critically ill and not expected to survive to discharge
• Grade IV intracerebral haemorrhage prior to enrolment into study.
• Unlikely to return for a 2 year follow-up
• Intervention unable to be continued until discharge home (step-down discharge unit not participating as a sub-site in the trial)

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)
Yes. Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified by gestation (< 28 weeks and 28 weeks 0 days to 31 weeks 6 days) where gestation is determined as postmenstrual age by best obstetric estimate.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Sample size to achieve 90 % power and alpha 0.05 is calculated at 954 infants, assuming a standard deviation of 15 points, a 10 % loss to follow-up and a 30 % adjustment for multiple births. Short term secondary outcomes will include enteral intake over the first 28 d, growth velocity (assessed weekly in hospital and every 2 months for the first 6 months post-discharge), neonatal morbidities (BPD/NEC/ROP/Sepsis/IVH), and length of hospital stay. Longer-term secondary outcomes will include survival, Bayley III sub-scores, percentages of the cohort with cognitive scores > 1 SD or 2 SD's below the mean; infant behaviour (ITSEA), growth, and health service utilisation. Health economics assessments will consider economic costs of length of stay, infant morbidity, health service utilisation, and neurodevelopmental outcome.
Data will be analysed in SPSS on an intention to treat basis by biostatisticians blind to study group assignment. Missing data will be handled via multiple imputation. Children unable to be tested on BSID-III due to disability, severe delay or perform below threshold for individual composite scores will be assigned a score of 49. Comparability of study groups at baseline will be based on patient demographic data as described above and baseline physiological circadian rhythmicity determined at randomisation. Descriptive statstics for all variables of interest will include mean(SD) for continuous measures and counts/percentages for categorical measures. Primary outcome will be analysed as a comparison of mean cognitive scores between the two groups at 24 months corrected postnatal age. Generalised estimating equations will be used with clustering of multiples adjusting for baseline stratification (gestation and centre). Secondary analysis will use a regression model adjusted for socioeconomic status, parental risk index, sex, birthweight z score, gestation age strata, centre, use of antenatal and postnatal steroids, multiple birth and a count of key neonatal morbidities. Circadian rhythmicity will be assessed using cosinor analysis (non-linear regression) to determine mesor, amplitude, and acrophase of rhythms. Significance will be set at p<0.05 and post-hoc testing performed with Tukey HSD.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
4/02/2019
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
954
Accrual to date
392
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 10004 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [2] 25674 0
Monash Children’s Hospital - Clayton
Recruitment hospital [3] 25675 0
Westmead Hospital - Westmead
Recruitment hospital [4] 25676 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 25677 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 25678 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [7] 25685 0
Monash Children’s Hospital - Clayton
Recruitment hospital [8] 25686 0
Westmead Hospital - Westmead
Recruitment hospital [9] 25687 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 25688 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [11] 25689 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [12] 25775 0
Monash Children’s Hospital - Clayton
Recruitment hospital [13] 25776 0
Westmead Hospital - Westmead
Recruitment hospital [14] 25777 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [15] 25778 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [16] 25779 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 19330 0
6008 - Subiaco
Recruitment postcode(s) [2] 41499 0
3169 - Clayton South
Recruitment postcode(s) [3] 41500 0
2145 - Westmead
Recruitment postcode(s) [4] 41501 0
6150 - Murdoch
Recruitment postcode(s) [5] 41502 0
2050 - Missenden Road
Recruitment postcode(s) [6] 41503 0
5006 - North Adelaide
Recruitment postcode(s) [7] 41510 0
3169 - Clayton South
Recruitment postcode(s) [8] 41511 0
2145 - Westmead
Recruitment postcode(s) [9] 41512 0
6150 - Murdoch
Recruitment postcode(s) [10] 41513 0
2050 - Missenden Road
Recruitment postcode(s) [11] 41514 0
5006 - North Adelaide
Recruitment postcode(s) [12] 41602 0
3169 - Clayton South
Recruitment postcode(s) [13] 41603 0
2145 - Westmead
Recruitment postcode(s) [14] 41604 0
6150 - Murdoch
Recruitment postcode(s) [15] 41605 0
2050 - Missenden Road
Recruitment postcode(s) [16] 41606 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 298655 0
Charities/Societies/Foundations
Name [1] 298655 0
Telethon Perth Children's Hospital Research Fund
Country [1] 298655 0
Australia
Funding source category [2] 309921 0
Government body
Name [2] 309921 0
West Australian Child Research Fund
Country [2] 309921 0
Australia
Funding source category [3] 309922 0
Government body
Name [3] 309922 0
National Health and Medical Research Council
Country [3] 309922 0
Australia
Funding source category [4] 314955 0
Charities/Societies/Foundations
Name [4] 314955 0
Channel 7 Telethon Trust
Country [4] 314955 0
Australia
Funding source category [5] 314959 0
Charities/Societies/Foundations
Name [5] 314959 0
Channel 7 Telethon Trust
Country [5] 314959 0
Australia
Funding source category [6] 315103 0
Charities/Societies/Foundations
Name [6] 315103 0
Channel 7 Telethon Trust
Country [6] 315103 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
Telethon Kids Institute
Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 297824 0
Individual
Name [1] 297824 0
J. Jane Pillow
Address [1] 297824 0
M309, School of Human Sciences
35 Stirling Highway,
Crawley, 6009, WA
Australia
Country [1] 297824 0
Australia
Other collaborator category [1] 282021 0
Other Collaborative groups
Name [1] 282021 0
Murdoch Children's Research Institute
Address [1] 282021 0
Flemington Road,
Parkville Victoria 3052
Australia
Country [1] 282021 0
Australia
Other collaborator category [2] 282828 0
University
Name [2] 282828 0
Monash University
Address [2] 282828 0
Wellington RoadClayton, Victoria3800
Country [2] 282828 0
Australia
Other collaborator category [3] 282829 0
University
Name [3] 282829 0
The University of Sydney
Address [3] 282829 0
Ross St,SydneyNSW 2006
Country [3] 282829 0
Australia
Other collaborator category [4] 282830 0
University
Name [4] 282830 0
The University of Western Australia
Address [4] 282830 0
35 Stirling HwyCrawley, 6009Western Australia
Country [4] 282830 0
Australia
Other collaborator category [5] 282831 0
University
Name [5] 282831 0
Monash University
Address [5] 282831 0
Wellington RoadClayton, Victoria3800
Country [5] 282831 0
Australia
Other collaborator category [6] 282832 0
University
Name [6] 282832 0
The University of Sydney
Address [6] 282832 0
Ross St,SydneyNSW 2006
Country [6] 282832 0
Australia
Other collaborator category [7] 282833 0
University
Name [7] 282833 0
The University of Western Australia
Address [7] 282833 0
35 Stirling HwyCrawley, 6009Western Australia
Country [7] 282833 0
Australia
Other collaborator category [8] 282857 0
University
Name [8] 282857 0
Monash University
Address [8] 282857 0
Wellington RoadClayton, Victoria3800
Country [8] 282857 0
Australia
Other collaborator category [9] 282858 0
University
Name [9] 282858 0
The University of Sydney
Address [9] 282858 0
Ross St,SydneyNSW 2006
Country [9] 282858 0
Australia
Other collaborator category [10] 282859 0
University
Name [10] 282859 0
The University of Western Australia
Address [10] 282859 0
35 Stirling HwyCrawley, 6009Western Australia
Country [10] 282859 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299610 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 299610 0
Ethics committee country [1] 299610 0
Australia
Date submitted for ethics approval [1] 299610 0
21/08/2018
Approval date [1] 299610 0
24/10/2018
Ethics approval number [1] 299610 0
RGS0000000954
Ethics committee name [2] 313934 0
Ramsay Health Care WA/SA
Ethics committee address [2] 313934 0
Ethics committee country [2] 313934 0
Australia
Date submitted for ethics approval [2] 313934 0
22/02/2018
Approval date [2] 313934 0
29/03/2019
Ethics approval number [2] 313934 0
HREC 2201W/1907
Ethics committee name [3] 313938 0
Ramsay Health Care WA/SA
Ethics committee address [3] 313938 0
Ethics committee country [3] 313938 0
Australia
Date submitted for ethics approval [3] 313938 0
22/02/2018
Approval date [3] 313938 0
29/03/2019
Ethics approval number [3] 313938 0
HREC 2201W/1907
Ethics committee name [4] 314043 0
Ramsay Health Care WA/SA
Ethics committee address [4] 314043 0
Ethics committee country [4] 314043 0
Australia
Date submitted for ethics approval [4] 314043 0
22/02/2018
Approval date [4] 314043 0
29/03/2019
Ethics approval number [4] 314043 0
HREC 2201W/1907

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

Contacts
Principal investigator
Name 81018 0
Prof Jane Pillow
Address 81018 0
M309, School of Human Sciences,
The University of Western Australia
35 Stirling Highway,
Crawley, 6009
Western Australia
Country 81018 0
Australia
Phone 81018 0
+61 417621960
Fax 81018 0
Email 81018 0
[email protected]
Contact person for public queries
Name 81019 0
Jane Pillow
Address 81019 0
M309, School of Human Sciences,
The University of Western Australia
35 Stirling Highway,
Crawley, 6009
Western Australia
Country 81019 0
Australia
Phone 81019 0
+61417621960
Fax 81019 0
Email 81019 0
[email protected]
Contact person for scientific queries
Name 81020 0
Jane Pillow
Address 81020 0
M309, School of Human Sciences,
The University of Western Australia
35 Stirling Highway,
Crawley, 6009
Western Australia
Country 81020 0
Australia
Phone 81020 0
+61417621960
Fax 81020 0
Email 81020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification;
When will data be available (start and end dates)?
Data will be available following the publication of study results. Short-term neonatal outcomes will be available after the trial recruitment target is reached (anticipated 31/3/2024). 2 year follow-up outcomes are expected to be available by 30/9/2026.
Study data will be available for approximately 25 years.
Available to whom?
Researchers who provide a methodologically sound proposal, at the discretion of the chief investigator and project sponsor
Available for what types of analyses?
For IPD meta-analysis, and potentially other analyses at the discretion of the chief investigator and project sponsor.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (PI) and requirement to sign a data access agreement. Potentially subject to agreement from participating sites/subsites.
The PI may be contacted at the study email address: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13562Study protocol    Documents will be uploaded after study protocol is... [More Details]
13563Statistical analysis plan  [email protected]
13564Informed consent form    374490-(Uploaded-02-04-2020-10-48-48)-Study-related document.pdf
13565Ethical approval    374490-(Uploaded-02-04-2020-10-51-41)-Study-related document.pdf
13566Clinical study report  [email protected]



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.