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Trial registered on ANZCTR
Registration number
ACTRN12615000940572
Ethics application status
Approved
Date submitted
26/02/2015
Date registered
8/09/2015
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of single versus multi-strain probiotic supplementation on the time to full enteral feeds in preterm neonates – a double blind randomised controlled trial
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Scientific title
Effect of single versus multi-strain probiotic supplementation on the time to full enteral feeds in preterm neonates – a double blind randomised controlled trial
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Secondary ID [1]
286278
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Nil known
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Secondary ID [2]
286583
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nil
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Universal Trial Number (UTN)
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Trial acronym
SiMPro Study (Single or Multiple Probiotics for neonates)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
enteral nutrition in preterm neonates
294344
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gut colonisation
294844
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faecal short chain fatty acids
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Condition category
Condition code
Oral and Gastrointestinal
294663
294663
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Diet and Nutrition
294664
294664
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0
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Other diet and nutrition disorders
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Reproductive Health and Childbirth
295113
295113
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0
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: Mixture of 3 strains (B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536 (1 billion CFU of each strain per 1 g sachet: 3-strains group)
Frequency of administration: 1 sachet per day when on minimal enteral feed, 2 sachets per day when > 50 ml/kg/day enteral feeds.
Duration of administration: From commencement of enteral feeds till 37 completed weeks of gestation
Mode of administration: reconstituted with breast milk, so oral liquid
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Intervention code [1]
291299
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Treatment: Other
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Comparator / control treatment
Control: Single strain product containing B. breve M-16V (3 billion CFU per 1 g sachet)
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Control group
Active
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Outcomes
Primary outcome [1]
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Time to full enteral feeds (time to achieve 150 ml/kg/day of enteral milk feeds from the day of randomisation) will be the time point for assessment of primary outcome
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Assessment method [1]
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Timepoint [1]
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from commencement of enteral feeds till 37 completed weeks of gestation
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Secondary outcome [1]
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All-cause mortality(clinical notes review within 1 month of mortality)
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Assessment method [1]
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0
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Timepoint [1]
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within 3-4 months of discharge from the hospital
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Secondary outcome [2]
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Gut flora and stool colonisation (assayed by conventional stool culture methods)
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Assessment method [2]
313269
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Timepoint [2]
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after completion of enrolment, preferably 3-4 months post discharge from hospital
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Secondary outcome [3]
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duration of parenteral nutrition (by review of inbuilt data available in our neonatal database)
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Assessment method [3]
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Timepoint [3]
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during patient stay in hospital or post discharge, within 3-4 months of patient discharge
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Secondary outcome [4]
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Necrotizing enterocolitis (NEC)
(assayed by clinical record review)
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Assessment method [4]
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Timepoint [4]
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after patient discharge, within 3-4 months following discharge of a patient
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Secondary outcome [5]
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Incidence of Late onset sepsis (assayed by blood tests and clinical examination)
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Assessment method [5]
314272
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Timepoint [5]
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after patient discharge, within 3-4 months following pateint discharge
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Secondary outcome [6]
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NEC related mortality (by review of medical records)
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Assessment method [6]
316614
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Timepoint [6]
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after patient death, within 1 month upto a maximum of 4 months post discharge
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Eligibility
Key inclusion criteria
(1) Gestation <28 weeks at birth (2) ready to commence on milk feeds or on milk feeds for <12 hours (3) Informed parental consent
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Minimum age
7
Days
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Maximum age
10
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) Congenital malformations (2) Chromosomal aberrations (3) Not ready for feeds or on feeds for > 12 hours
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All babies < 28 weeks gestation admitted into the neonatal nursery will be eligible for enrolment unless they satisfy the exclusion criteria of the study. Allocation concealment will be optimised by prescribing allocation only after informed parental consent and recording the basic neonatal data.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group assignment will be allocated by a computer generated randomisation sequence. Opaque, sealed, coded envelopes will be used for randomisation. Neonates of multiple pregnancies will be considered as separate individuals.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary end point is time to full enteral feeds (TFF) of 150 ml/kg/day. The current TFF (Mean +/- Std. Dev.) in neonates <28 weeks is 24 +/- 14.8 days. To demonstrate a 30% reduction in the TFF in the single vs. 3 strain probiotic group with 80% power and alpha 0.05 requires 75 neonates per group. To allow for attrition (15%) this will be increased to a total sample size of 172.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2015
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Actual
2/09/2015
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Date of last participant enrolment
Anticipated
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Actual
16/05/2017
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Date of last data collection
Anticipated
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Actual
28/02/2018
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Sample size
Target
172
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Accrual to date
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Final
172
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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King Edward Memorial Hospital - Subiaco
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Recruitment postcode(s) [1]
9287
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6008 - Subiaco
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Telethon and Channel 7 trust
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Address [1]
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Roberts road, Subiaco, WA, 6008
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Princess Margaret Hospital Foundation
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Address [2]
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Roberts road, Subiaco, 6008
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Gayatri Jape
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Address
Department of Neonatal Paediatrics
King Edward Memorial Hospital
Bagot road
Subiaco, 6008
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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NA
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Country [1]
289523
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Other collaborator category [1]
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University
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Name [1]
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University of Western Australia
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Address [1]
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35, Stirling highway
Crawley, 6009
Perth, Western Australia
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Country [1]
278369
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Womens and Newborns Health Reseacrh Ethics Committee
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Ethics committee address [1]
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Princess Margaret Hospital, CCRF buliding, Roberts road, SUbiaco, WA, 6008
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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03/03/2015
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Approval date [1]
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14/04/2015
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Ethics approval number [1]
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2015019EW
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Summary
Brief summary
Probiotics are live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host. Probiotics have been proven to reduce necrotizing enterocolitis, a devastating and life threatening emergency in neonates. Over recent years, the role of probiotics in improving gut motility and function has emerged. Probiotics, especially specific strains could improve nutrition in neonates by improving tolerance of oral feeds. Intolerance or poor tolerance of feeds along with repeated infections are some of the factors contributing to malnutrition in these high risk infants. Prevention of nutrition related issues in newborns will improve their long term development as well as their growth.
We propose to compare single strain probiotic as compared to multiple strain probiotic for their ability to improve oral feed tolerance in neonates. We will be administering either the single strain or multi strain probiotic after allotting the infant into either one or the other group and then examine the baby’s stool for presence of these good bacteria (contained in the probiotic). We will also be looking at the complex genetic structure of the bacteria in stool and study if probiotics could change the bad bacteria to good beneficial ones.
We will enrol all newborns less than 28 weeks of gestation, after parental consent. The probiotic supplements will be administered to the baby after starting oral feeds and continued till the baby is near term (37 weeks of gestation). Since probiotics improve intestinal motility, we will be investigating whether multiple strain probiotic will improve it to a better extent as compared to single strain probiotic. We will administer a small amount of dye orally to the infant and observe its excretion into stools. The better the effect on gut motility, the faster will be the excretion and shorter will be the time to excrete the dye as well.
In summary, this project will help us to conclude whether multiple strain probiotic will be more beneficial as compared to single strain for routine use in this high risk population.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gayatri Jape
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Address
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Department of Neonatal Paediatrics
King Edward Memorial Hospital
A block, first floor
374, Bagot road, Subiaco
WA, 6008
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Country
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Australia
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Phone
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+61893401260
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Fax
55374
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Karen Simmer
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Address
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Department of Neonatal Paediatrics
King Edward Memorial Hospital
A block, first floor
374, Bagot road, Subiaco
WA, 6008
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Country
55375
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Australia
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Phone
55375
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+61893401260
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Fax
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Email
55375
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[email protected]
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Contact person for scientific queries
Name
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Prof Sanjay Patole
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Address
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Department of Neonatal Paediatrics
King Edward Memorial Hospital
A block, first floor
374, Bagot road, Subiaco
WA, 6008
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Country
55376
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Australia
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Phone
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+61893401260
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Currently due to paucity of research support staff, it will be challenging to provide IPD information, also genomics and bolomics data is pending analysis.
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23373
Study protocol
[email protected]
23374
Clinical 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
Source
Title
Year of Publication
DOI
Embase
Current Status of Probiotics for Preterm Infants.
2021
https://dx.doi.org/10.1007/s12098-021-03736-2
Embase
Effect of single versus multistrain probiotic in extremely preterm infants: A randomised trial.
2022
https://dx.doi.org/10.1136/bmjgast-2021-000811
N.B. These documents automatically identified may not have been verified by the study sponsor.
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