An interventional study of Deferred cord clamping in Preterm Birth, sponsored by University of Sydney. Completed at 26 sites in 7 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by University of Sydney · Not applicable, Interventional, and Prevention
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 1,637 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
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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.
Immediate cord clamping (\< 10 seconds after birth). The cord is clamped 6 cm from the umbilicus within ten seconds of delivery of the baby.
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)
Death and/or major morbidity at 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.
Time frame: 36 weeks post menstrual age
Incidence of death
The death component of the composite primary outcome
Time frame: 36 completed weeks post menstrual age
Incidence of major morbidity
Major morbidity (incidence of one or more of brain injury on ultrasound, severe retinopathy, necrotising enterocolitis or late onset sepsis).
Time frame: 36 completed weeks post menstrual age
Incidence of death or major disability
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)
Time frame: Up to 3 years corrected age
Incidence of death or brain injury on ultrasound
Death or brain injury on ultrasound
Time frame: 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
Brain injury on ultrasound
Time frame: 36 completed weeks post menstrual age
IVH (all grades) seen on ultrasound
Time frame: 36 completed weeks post menstrual age
IVH (Grades 3 & 4) seen on ultrasound
Time frame: 36 completed weeks post menstrual age
IVH (Grade 4) seen on ultrasound
Time frame: 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
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
Patent ductus arteriosis requiring treatment (documented in medical records)
Time frame: 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
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
Death up to 3 years corrected age
Time frame: Up to 3 years corrected age
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Sydney