Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000633088
Ethics application status
Approved
Date submitted
30/07/2010
Date registered
2/08/2010
Date last updated
3/05/2021
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Prospectively registered

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] 252349 0
NCT02606058
Universal Trial Number (UTN)
Trial acronym
APTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre term birth 257809 0
Condition category
Condition code
Reproductive Health and Childbirth 257976 257976 0 0
Complications of newborn
Reproductive Health and Childbirth 257977 257977 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 257978 257978 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves deferring clamping of the cord after birth. The obstetrician or midwife holds the baby as low as possible below the level of the placenta for 60 seconds or more and then clamps the cord 6 cm from the about 6 cm from the umbilicus.
Intervention code [1] 256867 0
Other interventions
Comparator / control treatment
Immediate cord clamping (where the cord is clamped 6 cm from the umbilicus within 10 seconds of the delivery of the baby).
Control group
Active

Outcomes
Primary outcome [1] 258844 0
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] 258844 0
36 completed weeks post menstrual age
Secondary outcome [1] 265007 0
The death component of the composite primary outcome
Timepoint [1] 265007 0
36 completed weeks post menstrual age
Secondary outcome [2] 265008 0
Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).
Timepoint [2] 265008 0
36 completed weeks post menstrual age
Secondary outcome [3] 265009 0
In 2014, before any follow up outcomes were known, an application APP1086865 was submitted to NHMRC, titled "Does placental transfusion prevent death and disability in very preterm infants? Childhood follow-up in the NHMRC Australian Placental Transfusion Study". The Primary Outcome of the APTS Follow Up Study was defined as death or major disability in the 3rd year after birth (or survival without major disability at 2-3 years). Cerebral palsy, severe visual loss and deafness were determined from hospital records, physical examination or by parent report.

Major disability was defined by a positive result on;
(i) parent report on the Ages and Stages Questionnaire (ASQ),* or, if ASQ is unavailable,
(ii) a modified Short Health Status Questionnaire completed by a medically qualified
practitioner documenting either:-
(a) major developmental delay, including language or speech problems, or
(b) cerebral palsy with inability to walk unassisted at or after 2 yrs corrected age, or
(c) severe visual loss (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes), or
(d) deafness, requiring a hearing aid or cochlear implants.
Timepoint [3] 265009 0
up to 3 years corrected age
Secondary outcome [4] 326378 0
Death or brain injury on ultrasound
Timepoint [4] 326378 0
36 completed weeks post menstrual age
Secondary outcome [5] 326379 0
Death up to 3 years corrected age
Timepoint [5] 326379 0
Up to 3 years corrected age
Secondary outcome [6] 326380 0
The Secondary Outcomes of the APTS Follow Up Study, APP1086865, which were defined before any results of follow up were known, are:-

(1) Death at any time up to 3 years.
(2) Components of major disability at 3 years.
(3) ASQ overall and domain scores

Major disability outcomes were determined from hospital records or physical examination or parent report.
Timepoint [6] 326380 0
Up to 3 years corrected age
Secondary outcome [7] 326381 0
Brain injury on ultrasound
Timepoint [7] 326381 0
36 completed weeks post menstrual age
Secondary outcome [8] 326382 0
IVH (all grades) seen on ultrasound
Timepoint [8] 326382 0
36 completed weeks post menstrual age
Secondary outcome [9] 326383 0
IVH (Grades 3 & 4) seen on ultrasound
Timepoint [9] 326383 0
36 completed weeks post menstrual age
Secondary outcome [10] 326384 0
IVH (Grade 4) seen on ultrasound
Timepoint [10] 326384 0
36 completed weeks post menstrual age
Secondary outcome [11] 326385 0
Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions
Timepoint [11] 326385 0
36 completed weeks post menstrual age
Secondary outcome [12] 326386 0
Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.
Timepoint [12] 326386 0
36 completed weeks post menstrual age
Secondary outcome [13] 326387 0
Patent ductus arteriosis requiring treatment (documented in medical records)
Timepoint [13] 326387 0
36 completed weeks post menstrual age
Secondary outcome [14] 326388 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 [14] 326388 0
36 completed weeks post menstrual age
Secondary outcome [15] 326389 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 [15] 326389 0
36 completed weeks post menstrual age

Eligibility
Key inclusion criteria
Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been recieved from the parent or guardian.
Minimum age
No limit
Maximum age
No limit
Sex
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All mothers considered by the attending team to have reasonable chance of dleivering before 30 weeks will be approached for consent. Randomisation and treatment allocation will be completed by a member of the obstetric, neonatal or midwifery team. Central phone randomisation will be used. This is a computerised interactive voice response system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using an interactive voice response system built by an independent study statistician at the NHMRC Clinical Trials Centre, University of Sydney. All data will be stored securely by the statistical group at the centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/09/2010
Actual
8/12/2010
Date of last participant enrolment
Anticipated
Actual
6/01/2017
Date of last data collection
Anticipated
31/01/2020
Actual
9/09/2020
Sample size
Target
1600
Accrual to date
Final
1637
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 6378 0
The Canberra Hospital - Garran
Recruitment hospital [2] 6379 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 6380 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 6381 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [5] 6382 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 6383 0
Royal Hospital for Women - Randwick
Recruitment hospital [7] 6384 0
Nepean Hospital - Kingswood
Recruitment hospital [8] 6385 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 6386 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [10] 6387 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [11] 6388 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [12] 6389 0
The Townsville Hospital - Douglas
Recruitment hospital [13] 6390 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 6391 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 3055 0
2031
Recruitment postcode(s) [2] 3054 0
2050
Recruitment postcode(s) [3] 3053 0
2065
Recruitment postcode(s) [4] 13929 0
2170 - Liverpool
Recruitment postcode(s) [5] 13928 0
2305 - New Lambton
Recruitment postcode(s) [6] 3056 0
2605
Recruitment postcode(s) [7] 13930 0
2747 - Kingswood
Recruitment postcode(s) [8] 3059 0
3084
Recruitment postcode(s) [9] 3058 0
3168
Recruitment postcode(s) [10] 3060 0
4029
Recruitment postcode(s) [11] 13931 0
4101 - South Brisbane
Recruitment postcode(s) [12] 13932 0
4814 - Douglas
Recruitment postcode(s) [13] 3061 0
5042
Recruitment postcode(s) [14] 3063 0
6008
Recruitment outside Australia
Country [1] 7464 0
New Zealand
State/province [1] 7464 0
Auckland, Christchurch, Dunedin, Waikato, Wellington
Country [2] 7465 0
United Kingdom
State/province [2] 7465 0
Northern Ireland
Country [3] 7466 0
Pakistan
State/province [3] 7466 0
Karachi
Country [4] 7467 0
France
State/province [4] 7467 0
Paris
Country [5] 8074 0
United States of America
State/province [5] 8074 0
Vermont; Texas
Country [6] 8075 0
Canada
State/province [6] 8075 0
Nova Scotia

Funding & Sponsors
Funding source category [1] 257363 0
Government body
Name [1] 257363 0
National Health and Medical Research Council (NHMRC) project grant
Country [1] 257363 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Locked Bag 77 Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 256605 0
None
Name [1] 256605 0
Address [1] 256605 0
Country [1] 256605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259384 0
Northern Sydney Central Coast
Ethics committee address [1] 259384 0
Level 2, Building 51 Royal North Shore Hospital St Leonards NSW 2065
Ethics committee country [1] 259384 0
Australia
Date submitted for ethics approval [1] 259384 0
21/07/2010
Approval date [1] 259384 0
13/10/2010
Ethics approval number [1] 259384 0
HREC/10/HAWKE/94 (1007-272M)
Ethics committee name [2] 295633 0
Children's Health Queensland Hospital and Health Service HREC
Ethics committee address [2] 295633 0
Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [2] 295633 0
Australia
Date submitted for ethics approval [2] 295633 0
Approval date [2] 295633 0
29/04/2011
Ethics approval number [2] 295633 0
HREC/11/QRCH/12
Ethics committee name [3] 295634 0
Southern Health HREC B
Ethics committee address [3] 295634 0
Research Directorate, Southern Health
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Ethics committee country [3] 295634 0
Australia
Date submitted for ethics approval [3] 295634 0
Approval date [3] 295634 0
06/05/2011
Ethics approval number [3] 295634 0
HREC/11/SHB/3 (11031B)
Ethics committee name [4] 295635 0
Northern B Health and Disability Ethics Committee
Ethics committee address [4] 295635 0
Ministry of Health, Freyberg Building
20 Aitken St, PO Box 5013
Wellington, 6011
Ethics committee country [4] 295635 0
New Zealand
Date submitted for ethics approval [4] 295635 0
Approval date [4] 295635 0
13/03/2012
Ethics approval number [4] 295635 0
MEC/11/12/102
Ethics committee name [5] 295636 0
Mercy Health HREC
Ethics committee address [5] 295636 0
c/- Mercy Hospital for Women
Floor 6, Administration, 163 Studley Rd,
Heidelberg, VIC 3084
Ethics committee country [5] 295636 0
Australia
Date submitted for ethics approval [5] 295636 0
Approval date [5] 295636 0
17/05/2011
Ethics approval number [5] 295636 0
R11/16
Ethics committee name [6] 295637 0
ACT Health HREC
Ethics committee address [6] 295637 0
Building 10, Level 6, ACT Health Research Office
Canberra Hospital, ACT 2605
Ethics committee country [6] 295637 0
Australia
Date submitted for ethics approval [6] 295637 0
Approval date [6] 295637 0
01/06/2011
Ethics approval number [6] 295637 0
ETH. 3.11.049
Ethics committee name [7] 295638 0
WNHS Human Research Ethics Committee
Ethics committee address [7] 295638 0
King Edward Memorial Hospital
O Block
Entrance off Hensman Rd
Subiaco, Perth,
WA 6904
Ethics committee country [7] 295638 0
Australia
Date submitted for ethics approval [7] 295638 0
Approval date [7] 295638 0
06/05/2011
Ethics approval number [7] 295638 0
1879/EW
Ethics committee name [8] 295639 0
Southern Adelaide Clinical HREC
Ethics committee address [8] 295639 0
The Flats, F6/F8
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [8] 295639 0
Australia
Date submitted for ethics approval [8] 295639 0
Approval date [8] 295639 0
05/04/2011
Ethics approval number [8] 295639 0
006.11
Ethics committee name [9] 295640 0
CPP Ile de France XI Comite de Protection des Personnes
Ethics committee address [9] 295640 0
Pavillon Jacques Courtois - 2eme etage, 20 rue Armagis, 78105 Saint Germain-en-Laye Cedex
Ethics committee country [9] 295640 0
France
Date submitted for ethics approval [9] 295640 0
Approval date [9] 295640 0
25/07/2014
Ethics approval number [9] 295640 0
14052
Ethics committee name [10] 295641 0
Baylor College of Medicine IRB
Ethics committee address [10] 295641 0
Office of Research
One Baylor Plaza, 600D
Houston, Texas 77030
Ethics committee country [10] 295641 0
United States of America
Date submitted for ethics approval [10] 295641 0
Approval date [10] 295641 0
14/11/2014
Ethics approval number [10] 295641 0
H-34236
Ethics committee name [11] 295642 0
University of Vermont Committee on Human Subjects
Ethics committee address [11] 295642 0
Research Protections Office
213 Waterman Building
85 South Prospect St
Burlington, Vermont 05405
Ethics committee country [11] 295642 0
United States of America
Date submitted for ethics approval [11] 295642 0
Approval date [11] 295642 0
01/07/2014
Ethics approval number [11] 295642 0
CHRMS: 14-536
Ethics committee name [12] 295643 0
IWK Health Centre Research Ethics Board
Ethics committee address [12] 295643 0
IWK Health Centre - Research
5850/5980 University Ave
PO Box 9700, Halifax
Nova Scotia B3K 6R8
Ethics committee country [12] 295643 0
Canada
Date submitted for ethics approval [12] 295643 0
Approval date [12] 295643 0
11/12/2015
Ethics approval number [12] 295643 0
1018451
Ethics committee name [13] 295644 0
Aga Khan Univesity Ethical Review Committee
Ethics committee address [13] 295644 0
Stadium Rd, PO Box 3500
Karachi 74800
Ethics committee country [13] 295644 0
Pakistan
Date submitted for ethics approval [13] 295644 0
Approval date [13] 295644 0
03/05/2013
Ethics approval number [13] 295644 0
2451-Obs-ERC-13

Summary
Brief summary
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.
Trial website
http://www.ctc.usyd.edu.au/public-trial-pages/apts.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31430 0
Prof William Tarnow Mordi
Address 31430 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 31430 0
Australia
Phone 31430 0
+6129562 5000
Fax 31430 0
Email 31430 0
william.tarnow-mordi@ctc.usyd.edu.au
Contact person for public queries
Name 14677 0
Ms APTS Trial Coordinator
Address 14677 0
Locked Bag 77
Camperdown NSW 1450
Country 14677 0
Australia
Phone 14677 0
+61 2 9562 5000
Fax 14677 0
+61 2 9565 1863
Email 14677 0
apts@ctc.usyd.edu.au
Contact person for scientific queries
Name 5605 0
Prof Professor William Tarnow-Mordi
Address 5605 0
Locked Bag 77
Camperdown NSW 1450
Country 5605 0
Australia
Phone 5605 0
+ 61 2 9562 5062
Fax 5605 0
+ 61 2 9565 1863
Email 5605 0
william.tarnow-mordi@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data from the results reported in this study.
When will data be available (start and end dates)?
Individual de-identified participant data from the results reported in this study will be available for 5 years after publication. Researchers will need to sign a data access agreement.
Available to whom?
Researchers who submit a methodologically sound proposal with prior ethics approval who sign a data access agreement.
Available for what types of analyses?
individual participant data meta-analyses of similar trials.
How or where can data be obtained?
Researchers will need to provide a methodologically sound proposal with prior ethics approval to apts@ctc.usyd.edu. au and this will be reviewed by the trial management committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11555Study protocol  apts@ctc.usyd.edu.au
11556Statistical analysis plan  apts@ctc.usyd.edu.au
11557Informed consent form  apts@ctc.usyd.edu.au
11558Clinical study report  apts@ctc.usyd.edu.au
11559Analytic code  apts@ctc.usyd.edu.au
11560Ethical approval  apts@ctc.usyd.edu.au



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes The article was published on October 29, 2017, at ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDelayed versus Immediate Cord Clamping in Preterm Infants.2017https://dx.doi.org/10.1056/NEJMoa1711281
EmbaseEffect of Delayed Cord Clamping on Systemic Blood Flow: A Randomized Controlled Trial.2016https://dx.doi.org/10.1016/j.jpeds.2016.08.004
EmbaseContinuous local anaesthetic wound infusion of bupivacaine for postoperative analgesia in neonates: A randomised control trial (CANWIN Study).2022https://dx.doi.org/10.1136/bmjpo-2022-001586
N.B. These documents automatically identified may not have been verified by the study sponsor.