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Completed

NCT Number: NCT02606058

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?

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

deferred cord clamping

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Baylor College of Medicine
  • National Health and Medical Research Council, Australia

Registry information

Official study 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.

Acronym: APTS

Important dates

Study start
2010
Primary completion
2017
Study completion
2020
First posted
Nov 17, 2015
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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