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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02606058




Registration number
NCT02606058
Ethics application status
Date submitted
8/01/2015
Date registered
17/11/2015
Date last updated
5/11/2020

Titles & IDs
Public title
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?
Scientific title
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.
Secondary ID [1] 0 0
ACTRN12610000633088
Secondary ID [2] 0 0
H-34236
Universal Trial Number (UTN)
Trial acronym
APTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Birth 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Deferred cord clamping

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.

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.


Treatment: Surgery: Deferred cord clamping
Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death and/or major morbidity at 36 weeks post menstrual age - 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.
Timepoint [1] 0 0
36 weeks post menstrual age
Secondary outcome [1] 0 0
Incidence of death - The death component of the composite primary outcome
Timepoint [1] 0 0
36 completed weeks post menstrual age
Secondary outcome [2] 0 0
Incidence of major morbidity - Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).
Timepoint [2] 0 0
36 completed weeks post menstrual age
Secondary outcome [3] 0 0
Incidence of death or major disability - 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)
Timepoint [3] 0 0
Up to 3 years corrected age
Secondary outcome [4] 0 0
Incidence of death or brain injury on ultrasound - Death or brain injury on ultrasound
Timepoint [4] 0 0
36 completed weeks post menstrual age
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to 3 years corrected age
Secondary outcome [6] 0 0
Brain injury on ultrasound
Timepoint [6] 0 0
36 completed weeks post menstrual age
Secondary outcome [7] 0 0
IVH (all grades) seen on ultrasound
Timepoint [7] 0 0
36 completed weeks post menstrual age
Secondary outcome [8] 0 0
IVH (Grades 3 & 4) seen on ultrasound
Timepoint [8] 0 0
36 completed weeks post menstrual age
Secondary outcome [9] 0 0
IVH (Grade 4) seen on ultrasound
Timepoint [9] 0 0
36 completed weeks post menstrual age
Secondary outcome [10] 0 0
Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions
Timepoint [10] 0 0
36 completed weeks post menstrual age
Secondary outcome [11] 0 0
Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.
Timepoint [11] 0 0
36 completed weeks post menstrual age
Secondary outcome [12] 0 0
Patent ductus arteriosis requiring treatment (documented in medical records)
Timepoint [12] 0 0
36 completed weeks post menstrual age
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
36 completed weeks post menstrual age
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
36 completed weeks post menstrual age
Secondary outcome [15] 0 0
Death up to 3 years corrected age
Timepoint [15] 0 0
Up to 3 years corrected age

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No indication or contraindication to placental transfusion, in the view of mother or baby.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Hospital for Women - Sydney
Recruitment hospital [7] 0 0
Nepean Hospital - Sydney
Recruitment hospital [8] 0 0
Mater Mother's Hospital - Brisbane
Recruitment hospital [9] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [10] 0 0
Townsville Hospital - Townsville
Recruitment hospital [11] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
Mercy Hospital for Women - Melbourne
Recruitment hospital [14] 0 0
King Edward Memorial Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2065 - Sydney
Recruitment postcode(s) [6] 0 0
2170 - Sydney
Recruitment postcode(s) [7] 0 0
2747 - Sydney
Recruitment postcode(s) [8] 0 0
4029 - Brisbane
Recruitment postcode(s) [9] 0 0
4101 - Brisbane
Recruitment postcode(s) [10] 0 0
4814 - Townsville
Recruitment postcode(s) [11] 0 0
5042 - Adelaide
Recruitment postcode(s) [12] 0 0
3084 - Melbourne
Recruitment postcode(s) [13] 0 0
3168 - Melbourne
Recruitment postcode(s) [14] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
United States of America
State/province [2] 0 0
Vermont
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
France
State/province [4] 0 0
Clamart
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Dunedin
Country [8] 0 0
New Zealand
State/province [8] 0 0
Hamilton
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Pakistan
State/province [10] 0 0
Karachi
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Northern Ireland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Baylor College of Medicine
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To establish if placental transfusion, using deferred cord clamping for 60 seconds or more
while holding the baby at or below the level of the placenta, will improve survival without
disability compared with standard early cord clamping in preterm babies less than 30 weeks of
gestation.
Trial website
https://clinicaltrials.gov/show/NCT02606058
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William T Mordi, MD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications