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Trial registered on ANZCTR
Registration number
ACTRN12624000968572
Ethics application status
Approved
Date submitted
23/07/2024
Date registered
8/08/2024
Date last updated
8/08/2024
Date data sharing statement initially provided
8/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Autologous cord blood-derived cell therapy for extremely preterm infants: An international, multicentre randomised controlled trial
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Scientific title
Effect of autologous cord blood-derived cell therapy on neurodevelopment of extremely preterm infants: An international, multicentre randomised controlled trial
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Secondary ID [1]
312585
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Nil
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Universal Trial Number (UTN)
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Trial acronym
CORD-CELL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
prematurity
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preterm brain injury
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Condition category
Condition code
Reproductive Health and Childbirth
331125
331125
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0
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Complications of newborn
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Neurological
331182
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
One to two intravenous infusions of autologous umbilical cord blood derived cells (UCBCs) at a dose of 50 million total nucleated cells per kg given over 1 hour
Cord blood collected from baby's own umbilical cord, processed, UCBCs characterized, cryopreserved, and then infused when all testing confirms cell product is safe to use.
Infusion between Day 10-15 - one or two infusion depending on number of UCBCs extracted
Administered in participating neonatal units under site investigator supervision by a registered nurse using an intravenous pump.
Standard operating procedures will be harmonized across sites, with regular coordinating centre input and feedback.
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Intervention code [1]
329103
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Treatment: Other
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Comparator / control treatment
Placebo therapy (0.9% normal saline) given intravenously over 1 hour (1 or 2 infusions as per above)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Survival free of moderate-severe neurodisability at 24-30 months of corrected age (moderate-severe disability defined as any component of Bayley-4 (or III as available) scores less than 2 standard deviations (SD), cerebral palsy GMFCS grade >2, deafness, blindness (<6/60) or other moderate-severe neurological impairment)
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Assessment method [1]
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Assessments at 24-30 months:
Bayley -4
Gross Motor Function Classification System for cerebral palsy
Medical examination and interview
Vision and hearing testing
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Timepoint [1]
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24-30 months of corrected age
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Secondary outcome [1]
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Survival free of early features of significant neurodisability (based on General Movement Assessment, Hammersmith Infant Neurological Examination and medical assessment at 3-4 months corrected age (where available))
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Assessment method [1]
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General movement assessment
Hammersmith Infant Neurological Examination
Medical examination
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Timepoint [1]
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3-4 months corrected age
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Secondary outcome [2]
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Serious adverse events related to UCBC administration during and for 48 hrs post-infusion
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Assessment method [2]
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Observation and monitoring
Baby will be monitored closely for adverse events during and following the infusion of UCBCs.
During the infusion, and for the 24 hours following, we will closely monitor baby’s heart rate, breathing rate, oxygen saturations, blood pressure and temperature. We will monitor the infusion site for any redness or swelling and baby will be examined by a doctor more frequently than normal practice during this period.
We will monitor baby during their stay in the nursery as part of routine care.
After discharge from hospital, we will continue to monitor baby’s progress with appointments every 6 months until 2 years of age. These appointments will focus on baby’s general health and development. There will also be additional neurodevelopmental assessments at 3 months and 2 years corrected age, as is routine for extremely premature infants in most hospitals.
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Timepoint [2]
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24-48 hrs post cell infusion
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Secondary outcome [3]
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Death, until 24-30 months of corrected age
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Assessment method [3]
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Medical records
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Timepoint [3]
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24-30 months CA
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Secondary outcome [4]
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Bayley-4 (or III) individual scores as assessed at 24-30 months of corrected age
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Assessment method [4]
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Bayley-4 (or III)
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Timepoint [4]
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24-30 months CA
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Secondary outcome [5]
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Developmental delay, assessed any time until 24-30 months of corrected age
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Assessment method [5]
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Early assessments (HINE)
Late assessments (Bayley-4)
Medical assessment at any stage
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Timepoint [5]
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24-30 months CA
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Secondary outcome [6]
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Cerebral palsy (including GMFCS grade), assessed at 24 -30 months of corrected age
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Assessment method [6]
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GMFCS
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Timepoint [6]
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24-30 months CA
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Secondary outcome [7]
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Blindness (<6/60), assessed any time until 24-30 months corrected age
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Assessment method [7]
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Formal visual assessments conducted by ophthalmology (collected from medical records)
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Timepoint [7]
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24-30 months CA
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Secondary outcome [8]
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Deafness, assessed any time until 24-30 months corrected age
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Assessment method [8]
438237
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Formal audiology assessments conducted by audiology (collected from medical records)
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Timepoint [8]
438237
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24-30 months CA
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Secondary outcome [9]
438238
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Moderate to severe bronchopulmonary dysplasia, assessed at 36 weeks of postmenstrual age
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Assessment method [9]
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Discharge summary, medical records
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Timepoint [9]
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Term corrected age
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Secondary outcome [10]
438239
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Severe retinopathy of prematurity (needing treatment) or its sequalae, assessed anytime until 24-30 months corrected age
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Assessment method [10]
438239
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Ophthalmological assessment conducted by ophthalmology (collected from medical records)
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Timepoint [10]
438239
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24-30 months CA
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Secondary outcome [11]
438240
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Necrotising enterocolitis (>Bell’s stage IIa), assessed before neonatal discharge
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Assessment method [11]
438240
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Discharge summary, medical records
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Timepoint [11]
438240
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Neonatal discharge
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Secondary outcome [12]
438241
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Culture proven neonatal sepsis, assessed before neonatal discharge
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Assessment method [12]
438241
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Discharge summary, medical records
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Timepoint [12]
438241
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Neonatal discharge
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Secondary outcome [13]
438242
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Term equivalent age MRI findings (where available): brain injury score (Kidokoro)
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Assessment method [13]
438242
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MRI brain
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Timepoint [13]
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Term equivalent age
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Secondary outcome [14]
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Term equivalent age MRI findings (where available): growth measurements of brain structures
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Assessment method [14]
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MRI brain
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Timepoint [14]
438398
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Term equivalent age
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Eligibility
Key inclusion criteria
Extremely preterm infants born less than 28 weeks completed gestation
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Minimum age
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Days
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Maximum age
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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
Extremely preterm infants where parental consent could not be obtained, or where a major brain malformation was known antenatally.
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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)
Allocation concealment will happen automatically via the web-based system. Only members of the laboratory team (preparing the final product) will be aware of the allocation after eligibility has been confirmed and randomisation done. Coloured syringes and infusion tubing will be used to administer the intervention and control/placebo infusions.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using permuted random blocks and will be stratified by site and gestational age (less than or more than 26 weeks at birth).
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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 2 / Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/07/2029
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Actual
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Date of last data collection
Anticipated
31/07/2032
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Actual
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Sample size
Target
334
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment outside Australia
Country [1]
26445
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United States of America
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State/province [1]
26445
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Country [2]
26446
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Canada
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State/province [2]
26446
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Country [3]
26447
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Singapore
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State/province [3]
26447
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Funding & Sponsors
Funding source category [1]
317016
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Government body
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Name [1]
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Monash Health
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Address [1]
317016
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Country [1]
317016
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Australia
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Funding source category [2]
317020
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Government body
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Name [2]
317020
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NHMRC
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Address [2]
317020
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Country [2]
317020
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Australia
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Primary sponsor type
Government body
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Name
Monash Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319261
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University
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Name [1]
319261
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Monash University
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Address [1]
319261
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Country [1]
319261
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315772
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
315772
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
315772
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Australia
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Date submitted for ethics approval [1]
315772
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16/01/2024
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Approval date [1]
315772
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30/04/2024
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Ethics approval number [1]
315772
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Summary
Brief summary
Preterm infants, especially those born before 28 weeks of gestation, are at high risk of complications related to their brain and development. In this international research study conducted at multiple sites, cells (including stem cells) extracted from the baby’s own cord blood will be infused back to them. Babies will be randomised to treatment. It means half of the babies in the trial will receive their cord blood derived cells in the first two weeks of life (in some cases two infusions) in addition to routine neonatal intensive care, while the other half will only receive placebo treatment in the newborn intensive care unit. A randomised study is the most scientific way of assessing whether a treatment is beneficial. Further whether the baby receives the intervention will not be known to the parents, or the treating team. The main outcome studied in this trial will be baby’s survival at two years without major disability related to the brain. We expect that cord blood cell therapy may increase the baby’s chances of survival without any major disability, and if proven to be true at the end of this study, it may offer a new therapy for these vulnerable infants.
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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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A/Prof Atul Malhotra
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Address
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Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
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Country
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Australia
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Phone
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+61385723650
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Fax
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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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Atul Malhotra
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Address
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Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
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Country
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Australia
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Phone
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+61385723650
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Atul Malhotra
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Address
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Monash Health, 246 Clayton Rd, Clayton, VIC 3168.
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Country
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Australia
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Phone
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+61385723650
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Fax
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Email
135748
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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)?
No
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No/undecided IPD sharing reason/comment
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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.
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