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?

Preterm Birth Clinical Trial

— APTS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606058
• Other study ID #: H-34236
• Secondary ID: ACTRN12610000633
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1637
• Est. completion date: September 2020
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Adelaide	South Australia
Australia	Mater Mother's Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Mercy Hospital for Women	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	King Edward Memorial Hospital	Perth	Western Australia
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Nepean Hospital	Sydney	New South Wales
Australia	Royal Hospital for Women	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Townsville Hospital	Townsville	Queensland
Canada	IWK Health Center	Halifax	Nova Scotia
France	Hôpital Antoine-Béclère	Clamart
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Wellington
Pakistan	Aga Khan University Hospital	Karachi
United Kingdom	Royal Jubilee Maternity Hospital	Belfast	Northern Ireland
United Kingdom	Craigavon Area Hospital	Craigavon	Northern Ireland
United States	University of Vermont Medical Centre	Burlington	Vermont
United States	Baylor College of Medicine	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Sydney	Baylor College of Medicine, National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  New Zealand,  Pakistan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 weeks post menstrual age
Secondary	Incidence of death	The death component of the composite primary outcome	36 completed weeks post menstrual age
Secondary	Incidence of major morbidity	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
Secondary	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)	Up to 3 years corrected age
Secondary	Incidence of death or brain injury on ultrasound	Death or brain injury on ultrasound	36 completed weeks post menstrual age
Secondary	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.		Up to 3 years corrected age
Secondary	Brain injury on ultrasound		36 completed weeks post menstrual age
Secondary	IVH (all grades) seen on ultrasound		36 completed weeks post menstrual age
Secondary	IVH (Grades 3 & 4) seen on ultrasound		36 completed weeks post menstrual age
Secondary	IVH (Grade 4) seen on ultrasound		36 completed weeks post menstrual age
Secondary	Severe retinopathy warranting treatment or Stage 4 retinopathy according to the Australian and New Zealand Neonatal Network (ANZNN) definitions		36 completed weeks post menstrual age
Secondary	Necrotizing enterocolitis with the following signs: at least 1 systemic sign, profile consistent with definite NEC, warranted treatment for NEC.		36 completed weeks post menstrual age
Secondary	Patent ductus arteriosis requiring treatment (documented in medical records)		36 completed weeks post menstrual age
Secondary	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		36 completed weeks post menstrual age
Secondary	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.		36 completed weeks post menstrual age
Secondary	Death up to 3 years corrected age		Up to 3 years corrected age