- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606058
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? (APTS)
A Randomised Two Arm Open Label Controlled Trial Comparing Standard Immediate Cord Clamping Versus Deferring Cord Clamping for 60 Seconds or More in Babies Born Less Than 30 Weeks of Gestation to Determine Which Cord Clamping Method Results in Improved Survival and Less Disability.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by delaying the clamping of the umbilical cord by 60 seconds or more. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all very preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm, before it becomes even more widely used.
The Australian Placental Transfusion Study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. These participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. The main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Australian Capital Territory
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Canberra, Australian Capital Territory, Australia, 2605
- Canberra Hospital
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New South Wales
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Newcastle, New South Wales, Australia, 2305
- John Hunter Hospital
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Sydney, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Sydney, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Sydney, New South Wales, Australia, 2031
- Liverpool Hospital
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Sydney, New South Wales, Australia, 2170
- Royal Hospital for Women
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Sydney, New South Wales, Australia, 2747
- Nepean Hospital
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Queensland
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Brisbane, Queensland, Australia, 4029
- Mater Mother's Hospital
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Brisbane, Queensland, Australia, 4101
- Royal Brisbane and Women's Hospital
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Townsville, Queensland, Australia, 4814
- Townsville Hospital
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South Australia
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Adelaide, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Melbourne, Victoria, Australia, 3084
- Monash Medical Centre
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Melbourne, Victoria, Australia, 3168
- Mercy Hospital for Women
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Western Australia
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Perth, Western Australia, Australia, 6008
- King Edward Memorial Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K6BA
- IWK Health Center
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Clamart, France, 92140
- Hôpital Antoine-Béclère
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Auckland, New Zealand, 1023
- Auckland Hospital
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Christchurch, New Zealand, 4710
- Christchurch Hospital
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Dunedin, New Zealand, 9016
- Dunedin Hospital
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Hamilton, New Zealand, 3204
- Waikato Hospital
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Wellington, New Zealand, 6021
- Wellington Hospital
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Karachi, Pakistan, 74800
- Aga Khan University Hospital
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Northern Ireland
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Belfast, Northern Ireland, United Kingdom, BT12 6BA
- Royal Jubilee Maternity Hospital
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Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
- Craigavon Area Hospital
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
Exclusion Criteria:
No indication or contraindication to placental transfusion, in the view of mother or baby.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Early cord clamping (Control Arm)
Immediate cord clamping (< 10 seconds after birth).
The cord is clamped 6 cm from the umbilicus within ten seconds of delivery of the baby.
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Experimental: Deferred cord clamping
Deferred cord clamping.
Investigator/Research personnel holds the baby as low as possible below the level of the introitus or placenta for 60 seconds and not to exceed 80 seconds, then clamps the cord about 6 cm from the umbilicus.
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Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death and/or major morbidity at 36 weeks post menstrual age
Time Frame: 36 weeks post menstrual age
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Composite death and/or major morbidity at 36 completed weeks post menstrual age.
Morbidity is defined by one or more of the following: brain injury on ultrasound, severe retinopathy, necrotising enterocolitis, late onset sepsis.
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36 weeks post menstrual age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of death
Time Frame: 36 completed weeks post menstrual age
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The death component of the composite primary outcome
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36 completed weeks post menstrual age
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Incidence of major morbidity
Time Frame: 36 completed weeks post menstrual age
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Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).
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36 completed weeks post menstrual age
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Incidence of death or major disability
Time Frame: Up to 3 years corrected age
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Death or major disability (for example cerebral palsy with inability to walk; blindness; deafness; major problems with language or speech; ASQ score indicative of developmental delay)
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Up to 3 years corrected age
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Incidence of death or brain injury on ultrasound
Time Frame: 36 completed weeks post menstrual age
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Death or brain injury on ultrasound
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36 completed weeks post menstrual age
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Major disability defined as cerebral palsy with an inability to walk unassisted, severe visual loss, deafness, major problems with language or speech, or a score indicative of developmental delay on Ages and Stages Questionnaire.
Time Frame: Up to 3 years corrected age
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Up to 3 years corrected age
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Brain injury on ultrasound
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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IVH (all grades) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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IVH (Grades 3 & 4) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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IVH (Grade 4) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Patent ductus arteriosis requiring treatment (documented in medical records)
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Chronic lung disease, defined as receiving supplemental oxygen or any form of assisted ventilation at 36 completed weeks post menstrual age for 4 consecutive hours in a 24 hour period
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Late onset sepsis, defined as a clinical picture consistent with sepsis, and either a positive culture of blood and/or CSF, or a positive urine culture by sterile collection, and at least 5 days of antibiotic treatment.
Time Frame: 36 completed weeks post menstrual age
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36 completed weeks post menstrual age
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Death up to 3 years corrected age
Time Frame: Up to 3 years corrected age
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Up to 3 years corrected age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William T Mordi, MD, University of Sydney
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-34236
- ACTRN12610000633088 (Registry Identifier: Australian New Zealand Clinical Trials Registry)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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