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Trial registered on ANZCTR
Registration number
ACTRN12625000973415
Ethics application status
Approved
Date submitted
7/08/2025
Date registered
4/09/2025
Date last updated
4/09/2025
Date data sharing statement initially provided
4/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
DELIGHT Pilot Study: Delayed cord clamping in newborns with antenatal diagnosis of critical congenital heart disease
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Scientific title
Delayed cord clamping in newborns with antenatal diagnosis of critical congenital heart disease: a pilot randomised controlled trial examining effect of delayed cord clamping on haematocrit
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Secondary ID [1]
315033
0
None
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Universal Trial Number (UTN)
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Trial acronym
DELIGHT Pilot Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease
338454
0
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Condition category
Condition code
Reproductive Health and Childbirth
334752
334752
0
0
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Childbirth and postnatal care
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Cardiovascular
334785
334785
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is delayed clamping of the umbilical cord, for at least 60 seconds after delivery.
To administer the intervention:
* A nominated staff member (e.g. obstetrician or midwife) will call out clearly as soon as the infant has been delivered
* A nominated staff member (e.g. neonatal team member) will start the clock on the resuscitation trolley when the infant has been delivered and call out the time clearly in seconds.
* A nominated staff member (e.g. neonatal team member) will time and record the duration of the allocated intervention
* A nominated staff member (e.g. obstetrician or midwife) will record the time when the cord has been clamped.
The cord should be clamped 6 centimetres from the umbilicus. During the delay, the infant will be held in a sterile towel, at or up to 30 centimetres below the level of the vaginal introitus (for vaginal delivery) or the level of the incision (for Caesarean section). Time in seconds of cord clamping should be recorded. After cutting of the cord, the infant will receive routine care. If an infant is deemed to required immediate resuscitation, delayed cord clamping should be abandoned and the cord clamped immediately with time in seconds of cord clamping accurately recorded. Time in seconds of cord clamping should be recorded for all infants.
A secondary outcome of this study is to measure compliance to delayed cord clamping. This will be obtained by recording the reasons for not complying with the delay of 60 seconds in the broad categories of concern about pregnant individual, concern about infant, parent preference and others. Study teams should be counselled appropriately if a sustained pattern or non-compliance is determined by the coordinating centre as part of data monitoring.
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Intervention code [1]
331681
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Prevention
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Comparator / control treatment
The comparator is early clamping of the umbilical cord within 15 seconds after delivery of the infant.
To administer the intervention:
* A nominated staff member (e.g. obstetrician or midwife) will call out clearly as soon as the infant has been delivered
* A nominated staff member (e.g. neonatal team member) will start the clock on the resuscitation trolley when the infant has been delivered and call out the time clearly in seconds.
* A nominated staff member (e.g. neonatal team member) will time and record the duration of the allocated intervention
* A nominated staff member (e.g. obstetrician or midwife) will record the time when the cord has been clamped.
The cord should be clamped 6 centimetres from the umbilicus. During the delay, the infant will be held in a sterile towel, at or up to 30 centimetres below the level of the vaginal introitus (for vaginal delivery) or the level of the incision (for Caesarean section). Time in seconds of cord clamping should be recorded. After cutting of the cord, the infant will receive routine care. Time in seconds of cord clamping should be recorded for all infants.
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Control group
Active
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Outcomes
Primary outcome [1]
342399
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Haematocrit
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Assessment method [1]
342399
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As measured by full blood count
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Timepoint [1]
342399
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At admission to the neonatal intensive care unit (no later than 6 hours of life)
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Secondary outcome [1]
450694
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Haemoglobin
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Assessment method [1]
450694
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As measured by full blood count.
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Timepoint [1]
450694
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At admission to the neonatal intensive care unit (no later than 6 hours of life)
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Secondary outcome [2]
450741
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Proportion of infants who receive at least one packed cell transfusion
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Assessment method [2]
450741
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As documented in medical records
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Timepoint [2]
450741
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From birth until hospital discharge
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Secondary outcome [3]
450742
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Number of packed red blood cell transfusions
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Assessment method [3]
450742
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As documented in medical records
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Timepoint [3]
450742
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From birth until hospital discharge
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Secondary outcome [4]
450743
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Proportion of infants who receive inotropic medication
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Assessment method [4]
450743
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As documented in medical records. Details of the actual medication administered and doses will not be collected.
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Timepoint [4]
450743
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At any time in the first 24 hours of life, commencing from time of birth.
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Secondary outcome [5]
450745
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Proportion of infants who experience hypotension
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Assessment method [5]
450745
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As documented in medical records. The DELIGHT pilot study will use the most common definition of hypotension used in neonates: mean arterial blood pressure less than the gestational age in weeks.
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Timepoint [5]
450745
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At any time in the first 24 hours of life, commencing from time of birth
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Secondary outcome [6]
450746
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Consent rate
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Assessment method [6]
450746
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Proportion of participants consented, of total eligible participants as documented on the screening log. Reasons for non-consent should be documented where feasible.
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Timepoint [6]
450746
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At the conclusion of recruitment
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Secondary outcome [7]
450747
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Recruitment rate
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Assessment method [7]
450747
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Proportion of participants randomised, of total eligible and consented participants as documented on the screening log and final list of randomised participants. Reasons for non-participation should be documented.
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Timepoint [7]
450747
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At the conclusion of recruitment
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Secondary outcome [8]
450749
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Recruitment rate within different severity categories (composite)
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Assessment method [8]
450749
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Proportion of participants randomised, within different severity categories, defined by Foetal Cardiovascular Disease Severity Scale (FDSS) score, of total eligible and consented participants as documented on the screening log and final list of randomised participants.
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Timepoint [8]
450749
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At the conclusion of recruitment
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Secondary outcome [9]
450751
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Compliance to delayed cord clamping
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Assessment method [9]
450751
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This composite measurement will be obtained by recording the reasons for not complying with the delay of 60 seconds in the broad categories of concern about pregnant individual, concern about infant, parent preference and others. Data will be recorded within medical records or study-specific data capture forms.
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Timepoint [9]
450751
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At the conclusion of the study intervention period
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Secondary outcome [10]
450753
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (hospital stay)
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Assessment method [10]
450753
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): hospital stay in days
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Timepoint [10]
450753
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From NICU admission to hospital discharge
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Secondary outcome [11]
450754
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Safety outcome measures
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Assessment method [11]
450754
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Rates of serious adverse events associated with delayed cord clamping versus early cord clamping, obtained via review of medical records.
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Timepoint [11]
450754
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From birth to 72 hours of life
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Secondary outcome [12]
451185
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of 3-4 month follow-up outcome data as a primary outcome for definitive RCT
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Assessment method [12]
451185
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General movements assessment and Hammersmith Infant Neurological exam (where feasible or routinely performed)
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Timepoint [12]
451185
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3-4 months corrected for prematurity
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Secondary outcome [13]
451186
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of 12 month follow-up outcome data as a primary outcome for definitive RCT (subject to further funding)
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Assessment method [13]
451186
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Bayley-IV
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Timepoint [13]
451186
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12 months corrected for prematurity
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Secondary outcome [14]
451578
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (survival to discharge)
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Assessment method [14]
451578
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): survival to hospital discharge
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Timepoint [14]
451578
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From NICU admission to hospital discharge or 30 days after cardiac intervention (whichever is earlier)
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Secondary outcome [15]
451579
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (necrotising enterocolitis)
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Assessment method [15]
451579
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): necrotising enterocolitis treated medically or surgically
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Timepoint [15]
451579
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Prior to cardiac intervention
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Secondary outcome [16]
451580
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (shock)
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Assessment method [16]
451580
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): shock persistent at or resolved at the time of cardiac intervention
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Timepoint [16]
451580
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Prior to cardiac intervention
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Secondary outcome [17]
451581
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (mechanical ventilation)
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Assessment method [17]
451581
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): mechanical ventilation to treat cardiorespiratory failure prior to cardiac intervention
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Timepoint [17]
451581
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Prior to cardiac intervention
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Secondary outcome [18]
451582
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (renal failure)
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Assessment method [18]
451582
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): renal failure requiring dialysis prior to cardiac intervention
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Timepoint [18]
451582
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Prior to cardiac intervention
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Secondary outcome [19]
451583
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - bleeding)
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Assessment method [19]
451583
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - bleeding. Only applicable for infants receiving cardiac surgery.
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Timepoint [19]
451583
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [20]
451584
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - multi-system organ failure)
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Assessment method [20]
451584
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - multi-system organ failure.
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Timepoint [20]
451584
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [21]
451585
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - mechanical circulatory support)
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Assessment method [21]
451585
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - mechanical circulatory support
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Timepoint [21]
451585
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [22]
451586
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - respiratory insufficiency)
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Assessment method [22]
451586
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - respiratory insufficiency requiring mechanical ventilatory support
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Timepoint [22]
451586
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From cardiac intervention to greater than 7 days after cardiac intervention.
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Secondary outcome [23]
451587
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - persistent neurological deficit)
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Assessment method [23]
451587
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - neurological deficit persistent at discharge.
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Timepoint [23]
451587
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From cardiac intervention to hospital discharge
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Secondary outcome [24]
451588
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - transient neurological deficit)
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Assessment method [24]
451588
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - transient neurological deficit not persistent at discharge.
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Timepoint [24]
451588
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From cardiac intervention to hospital discharge
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Secondary outcome [25]
451589
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - respiratory failure requiring tracheostomy)
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Assessment method [25]
451589
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - respiratory failure requiring tracheostomy
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Timepoint [25]
451589
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [26]
451590
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - unplanned cardiac reoperation)
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Assessment method [26]
451590
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - unplanned cardiac reoperation, exclusive of reoperation for bleeding. Only applicable for infants receiving cardiac surgery.
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Timepoint [26]
451590
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [27]
451591
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - unplanned interventional cardiovascular catheterisation procedure)
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Assessment method [27]
451591
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - unplanned interventional cardiovascular catheterisation procedure.
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Timepoint [27]
451591
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [28]
451592
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - acute renal failure requiring dialysis)
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Assessment method [28]
451592
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - acute renal failure requiring dialysis at the time of death or hospital discharge.
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Timepoint [28]
451592
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At death or hospital discharge
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Secondary outcome [29]
451593
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - acute renal failure requiring temporary dialysis)
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Assessment method [29]
451593
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - acute renal failure requiring temporary dialysis with the need for dialysis not present at the time of death or hospital discharge.
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Timepoint [29]
451593
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At death or hospital discharge
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Secondary outcome [30]
451594
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - cardiac arrest during or following cardiac intervention)
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Assessment method [30]
451594
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - cardiac arrest during or following cardiac intervention.
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Timepoint [30]
451594
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From cardiac intervention to 30 days after cardiac intervention or prior to hospital discharge (if discharged >30 days)
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Secondary outcome [31]
451595
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Refinement of a suitable primary outcome measure for definitive randomised controlled trial (RCT): feasibility of hospital outcome data as a primary outcome for definitive RCT (complications - unplanned readmission to hospital)
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Assessment method [31]
451595
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Hospital outcomes collected from site or from Australia and New Zealand Congenital Outcomes Registry for Surgery (ANZCORS): complications - unplanned readmission to hospital
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Timepoint [31]
451595
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Within 30 days following cardiac intervention.
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Eligibility
Key inclusion criteria
1. Term or late preterm foetus, greater than 34 weeks gestation, with an antenatal diagnosis of critical congenital heart disease diagnosed by foetal cardiologist
2. Antenatal foetal cardiovascular disease severity scale (FDSS) score of 3-6 (inclusive)
3. Written informed consent provided by the pregnant individual (parent)
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Minimum age
34
Weeks
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Maximum age
No limit
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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. Foetuses with known genetic or major extracardiac anomalies, including Trisomy 21
2. Foetuses for whom palliative care is planned from delivery
3. Foetuses of pregnant individuals with current placental abruption or placenta previa
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Study design
Purpose of the study
Prevention
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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)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of generating the allocation sequence is computer generated random numbers. Randomisation will be via permuted block randomisation. The randomisation will be stratified by hospital site (2 sites) and FDSS score (5-6 vs. 3-4).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A sample size of 90 infants (45 per treatment arm) would provide 90% power (alpha=0.05) to detect superiority of delayed cord clamping over early cord clamping, assuming a mean difference in haematocrit of 5%, a standard deviation of 5 and accounting for 30% non-compliance.
All analyses will be prespecified in a statistical analysis plan and performed by intention to treat. Haematocrit will be analysed using a 2-sample t-test, and a mean difference (with 95% confidence interval) will be calculated. Other outcomes will be calculated as proportions or means with 95% confidence intervals.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last participant enrolment
Anticipated
1/01/2027
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Actual
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Date of last data collection
Anticipated
31/03/2027
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Funding & Sponsors
Funding source category [1]
319597
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Government body
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Name [1]
319597
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Commonwealth Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF)
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Address [1]
319597
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Country [1]
319597
0
Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
322099
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None
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Name [1]
322099
0
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Address [1]
322099
0
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Country [1]
322099
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318162
0
Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
318162
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https://www.hnehealth.nsw.gov.au/research-office/research_ethics
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Ethics committee country [1]
318162
0
Australia
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Date submitted for ethics approval [1]
318162
0
31/07/2025
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Approval date [1]
318162
0
20/08/2025
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Ethics approval number [1]
318162
0
2025/ETH01678
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Summary
Brief summary
Waiting at least 60 seconds before clamping the umbilical cord ("delayed cord clamping") is recommended in uncomplicated pregnancies to reduce anaemia, death and disability. However, babies with a heart defect diagnosed before birth have not been included in the studies on which these recommendations were based. This study will examine whether delayed cord clamping improves the proportion of red blood cells ("haematocrit”) in the blood of babies born after 34 weeks of pregnancy with a serious heart defect ("critical congenital heart disease") that was diagnosed before birth, compared to early cord clamping. It will also examine the feasibility of a larger definitive trial that would examine whether delayed cord clamping improves health outcomes for these babies in the longer term. Data will be collected to approx. 3-4 months of age, or to approx. 12 months of age subject to further funding. A total of 90 infants will be recruited.
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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
143310
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Dr Himanshu Popat
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Address
143310
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NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
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Country
143310
0
Australia
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Phone
143310
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+61 2 9845 2714
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Fax
143310
0
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Email
143310
0
[email protected]
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Contact person for public queries
Name
143311
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Ms Sarah Finlayson
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Address
143311
0
NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
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Country
143311
0
Australia
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Phone
143311
0
+61 2 9562 5347
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Fax
143311
0
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Email
143311
0
[email protected]
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Contact person for scientific queries
Name
143312
0
Himanshu Popat
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Address
143312
0
NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
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Country
143312
0
Australia
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Phone
143312
0
+61 2 9845 2714
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Fax
143312
0
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Email
143312
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
•
Requires a scientifically sound proposal or protocol
•
Requires approval by an ethics committee
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Provide request in writing to
[email protected]
Are there extra considerations when requesting access to individual participant data?
Yes:
Data sharing must comply with University of Sydney policies, and NHMRC Clinical Trial Centre SOPs. Data sharing can only be performed in line with the consent given by participants.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
To be published in peer-reviewed journal
Statistical analysis plan
To be published in peer-reviewed journal
Informed consent form
Anticipated to be provided as supplementary materi...
[
More Details
]
Ethical approval
DELIGHT_HRECApproval_InitialSubmission_20250820 (1).pdf
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.
Download to PDF