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?

• Register: ANZCTR
• Last refreshed on: 10 May 2021
• Main ID: ACTRN12610000633088
• Date of registration: 02/08/2010
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• 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.
• Date of first enrolment: 08/12/2010
• Target sample size: 1600
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000633088.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Canada, France, New Zealand, Pakistan, United Kingdom, United States of America

Contacts

• Name: Ms APTS Trial Coordinator

• Name: Prof Professor William Tarnow-Mordi

Key inclusion & exclusion criteria

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.
Exclusion criteria: No indication or contraindication to placental transfusion, in the view of mother or baby.

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Complications of newborn

Reproductive Health and Childbirth - Childbirth and postnatal care

Pre term birth;
Pre term birth

Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

Intervention(s)

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.

Primary Outcome(s)

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.[36 completed weeks post menstrual age]

Secondary Outcome(s)

Death up to 3 years corrected age[Up to 3 years corrected age]

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.

[up to 3 years corrected age]

Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).[36 completed weeks post menstrual age]

Brain injury on ultrasound[36 completed weeks post menstrual age]

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.[36 completed weeks post menstrual age]

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.[Up to 3 years corrected age]

Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.[36 completed weeks post menstrual age]

IVH (Grades 3 & 4) seen on ultrasound[36 completed weeks post menstrual age]

IVH (all grades) seen on ultrasound [36 completed weeks post menstrual age]

Death or brain injury on ultrasound[36 completed weeks post menstrual age]

Patent ductus arteriosis requiring treatment (documented in medical records)[36 completed weeks post menstrual age]

Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions[36 completed weeks post menstrual age]

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[36 completed weeks post menstrual age]

The death component of the composite primary outcome[36 completed weeks post menstrual age]

IVH (Grade 4) seen on ultrasound[36 completed weeks post menstrual age]

Secondary ID(s)

NCT02606058

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC) project grant

Ethics review

Status: Approved
Approval date: 13/10/2010
Contact:

Status: Approved
Approval date: 05/04/2011
Contact:

Status: Approved
Approval date: 29/04/2011
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Status: Approved
Approval date: 06/05/2011
Contact:

Status: Approved
Approval date: 17/05/2011
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Status: Approved
Approval date: 01/06/2011
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Status: Approved
Approval date: 13/03/2012
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Status: Approved
Approval date: 03/05/2013
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Status: Approved
Approval date: 01/07/2014
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Status: Approved
Approval date: 25/07/2014
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Status: Approved
Approval date: 14/11/2014
Contact:

Status: Approved
Approval date: 11/12/2015
Contact:

Results

• Results available: Yes
• Date Posted: 14/11/2018
• Date Completed: 09/09/2020