Clinical trial 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?
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Baylor College of Medicine
First posted: 2015-11-17
Enrollment: 1637
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Death and/or major morbidity at 36 weeks post menstrual age
timeFrame: 36 weeks post menstrual age
Secondary outcomes:
measure: Incidence of death
timeFrame: 36 completed weeks post menstrual age
measure: Incidence of major morbidity
timeFrame: 36 completed weeks post menstrual age
measure: Incidence of death or major disability
timeFrame: Up to 3 years corrected age
measure: Incidence of death or brain injury on ultrasound
timeFrame: 36 completed weeks post menstrual age
measure: 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.
timeFrame: Up to 3 years corrected age
measure: Brain injury on ultrasound
timeFrame: 36 completed weeks post menstrual age
measure: IVH (all grades) seen on ultrasound
timeFrame: 36 completed weeks post menstrual age
measure: IVH (Grades 3 & 4) seen on ultrasound
timeFrame: 36 completed weeks post menstrual age
measure: IVH (Grade 4) seen on ultrasound
timeFrame: 36 completed weeks post menstrual age
measure: Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions
timeFrame: 36 completed weeks post menstrual age
measure: Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.
timeFrame: 36 completed weeks post menstrual age
measure: Patent ductus arteriosis requiring treatment (documented in medical records)
timeFrame: 36 completed weeks post menstrual age
measure: 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
timeFrame: 36 completed weeks post menstrual age
measure: 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.
timeFrame: 36 completed weeks post menstrual age
measure: Death up to 3 years corrected age
timeFrame: Up to 3 years corrected age
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Centre
state: Vermont
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Hospital for Women
state: New South Wales
city: Sydney
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Mother's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Mercy Hospital for Women
state: Victoria
city: Perth
country: Australia
facility: King Edward Memorial Hospital
state: Western Australia
city: Halifax
country: Canada
facility: IWK Health Center
state: Nova Scotia
city: Clamart
country: France
facility: Hôpital Antoine-Béclère
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
city: Belfast
country: United Kingdom
facility: Royal Jubilee Maternity Hospital
state: Northern Ireland
city: Craigavon
country: United Kingdom
facility: Craigavon Area Hospital
state: Northern Ireland
Study officials:
affiliation: University of Sydney
name: William T Mordi, MD
role: PRINCIPAL_INVESTIGATOR
References: