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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)

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ClinicalTrials.gov Identifier: NCT02606058
Recruitment Status : Active, not recruiting
First Posted : November 17, 2015
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Baylor College of Medicine
Information provided by (Responsible Party):
University of Sydney

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: Deferred cord clamping Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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.
Actual Study Start Date : September 2010
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : January 2020

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of death [ Time Frame: 36 completed weeks post menstrual age ]
    The death component of the composite primary outcome

  2. 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).

  3. 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)

  4. Incidence of death or brain injury on ultrasound [ Time Frame: 36 completed weeks post menstrual age ]
    Death or brain injury on ultrasound

  5. 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 ]
  6. Brain injury on ultrasound [ Time Frame: 36 completed weeks post menstrual age ]
  7. IVH (all grades) seen on ultrasound [ Time Frame: 36 completed weeks post menstrual age ]
  8. IVH (Grades 3 & 4) seen on ultrasound [ Time Frame: 36 completed weeks post menstrual age ]
  9. IVH (Grade 4) seen on ultrasound [ Time Frame: 36 completed weeks post menstrual age ]
  10. 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 ]
  11. 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 ]
  12. Patent ductus arteriosis requiring treatment (documented in medical records) [ Time Frame: 36 completed weeks post menstrual age ]
  13. 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 ]
  14. 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 ]
  15. Death up to 3 years corrected age [ Time Frame: Up to 3 years corrected age ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606058


  Show 26 Study Locations
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Baylor College of Medicine
Investigators
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Principal Investigator: William T Mordi, MD University of Sydney

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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02606058     History of Changes
Other Study ID Numbers: H-34236
ACTRN12610000633088 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications