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)

November 4, 2020 updated by: University of Sydney

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.

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

1637

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Newcastle, New South Wales, Australia, 2305
        • John Hunter Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Sydney, New South Wales, Australia, 2031
        • Liverpool Hospital
      • Sydney, New South Wales, Australia, 2170
        • Royal Hospital for Women
      • Sydney, New South Wales, Australia, 2747
        • Nepean Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Mater Mother's Hospital
      • Brisbane, Queensland, Australia, 4101
        • Royal Brisbane and Women's Hospital
      • Townsville, Queensland, Australia, 4814
        • Townsville Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3084
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3168
        • Mercy Hospital for Women
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • King Edward Memorial Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K6BA
        • IWK Health Center
      • Clamart, France, 92140
        • Hôpital Antoine-Béclère
      • Auckland, New Zealand, 1023
        • Auckland Hospital
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Wellington, New Zealand, 6021
        • Wellington Hospital
      • Karachi, Pakistan, 74800
        • Aga Khan University Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BA
        • Royal Jubilee Maternity Hospital
      • Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
        • Craigavon Area Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
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 weeks post menstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of death
Time Frame: 36 completed weeks post menstrual age
The death component of the composite primary outcome
36 completed weeks post menstrual age
Incidence of major morbidity
Time Frame: 36 completed weeks post menstrual 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
Incidence of death or major disability
Time Frame: Up to 3 years corrected age
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)
Up to 3 years corrected age
Incidence of death or brain injury on ultrasound
Time Frame: 36 completed weeks post menstrual age
Death or brain injury on ultrasound
36 completed weeks post menstrual age
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
Up to 3 years corrected age
Brain injury on ultrasound
Time Frame: 36 completed weeks post menstrual age
36 completed weeks post menstrual age
IVH (all grades) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
36 completed weeks post menstrual age
IVH (Grades 3 & 4) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
36 completed weeks post menstrual age
IVH (Grade 4) seen on ultrasound
Time Frame: 36 completed weeks post menstrual age
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
Time Frame: 36 completed weeks post menstrual age
36 completed weeks post menstrual age
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
36 completed weeks post menstrual age
Patent ductus arteriosis requiring treatment (documented in medical records)
Time Frame: 36 completed weeks post menstrual age
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
Time Frame: 36 completed weeks post menstrual age
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.
Time Frame: 36 completed weeks post menstrual age
36 completed weeks post menstrual age
Death up to 3 years corrected age
Time Frame: Up to 3 years corrected age
Up to 3 years corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: William T Mordi, MD, University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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