Preterm BirthAPTSNCT02606058
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?
A study testing Deferred cord clamping in people with Preterm Birth, run by University of Sydney at 26 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Deferred cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,637 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Sep 2010to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
Who cannot join
- No indication or contraindication to placental transfusion, in the view of mother or baby.
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
Australia14 sites
Flinders Medical Centre
Adelaide, South Australia, 5042
Mater Mother's Hospital
Brisbane, Queensland, 4029
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4101
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Monash Medical Centre
Melbourne, Victoria, 3084
Mercy Hospital for Women
Melbourne, Victoria, 3168
John Hunter Hospital
Newcastle, New South Wales, 2305
King Edward Memorial Hospital
Perth, Western Australia, 6008
Liverpool Hospital
Sydney, New South Wales, 2031
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Royal North Shore Hospital
Sydney, New South Wales, 2065
Royal Hospital for Women
Sydney, New South Wales, 2170
Nepean Hospital
Sydney, New South Wales, 2747
Townsville Hospital
Townsville, Queensland, 4814
New Zealand5 sites
Auckland Hospital
Auckland, 1023
Christchurch Hospital
Christchurch, 4710
Dunedin Hospital
Dunedin, 9016
Waikato Hospital
Hamilton, 3204
Wellington Hospital
Wellington, 6021
United States2 sites
University of Vermont Medical Centre
Burlington, Vermont, 05401
Baylor College of Medicine
Houston, Texas, 77030
United Kingdom2 sites
Royal Jubilee Maternity Hospital
Belfast, Northern Ireland, BT12 6BA
Craigavon Area Hospital
Craigavon, Northern Ireland, BT63 5QQ
About this study
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.
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Deferred cord clamping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferred cord clampingProcedure or surgery
Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping (Control Arm) | No intervention | 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 | Experimental | 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. Receives: Procedure: Deferred cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks post menstrual age
Secondary outcomes (15)
Incidence of death
The death component of the composite primary outcome
Measured: 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).
Measured: 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)
Measured: Up to 3 years corrected age
Incidence of death or brain injury on ultrasound
Death or brain injury on ultrasound
Measured: 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.
Measured: Up to 3 years corrected age
Brain injury on ultrasound
Measured: 36 completed weeks post menstrual age
IVH (all grades) seen on ultrasound
Measured: 36 completed weeks post menstrual age
IVH (Grades 3 & 4) seen on ultrasound
Measured: 36 completed weeks post menstrual age
IVH (Grade 4) seen on ultrasound
Measured: 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
Measured: 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.
Measured: 36 completed weeks post menstrual age
Patent ductus arteriosis requiring treatment (documented in medical records)
Measured: 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
Measured: 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.
Measured: 36 completed weeks post menstrual age
Death up to 3 years corrected age
Measured: Up to 3 years corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startSep 2010
- Primary completionApr 2017
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- William T Mordi, MD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606058
- Sponsor's protocol ID
- H-34236
- Other IDs
- ACTRN12610000633088
- Acronym
- APTS
- Status last verified
- Nov 2020
- First submitted
- 8 Jan 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02606058
- Acronym / sponsor ID
- APTS / H-34236
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,637 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Baylor College of Medicine
- Study start
- Sep 2010 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping (Control Arm) | No intervention | –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 | Experimental | Procedure: Deferred cord clampingDeferred 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.
Key exclusion criteria (1 listed)
- No indication or contraindication to placental transfusion, in the view of mother or baby.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferred cord clampingDeferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta) | Procedure or surgery | Deferred cord clamping |
Primary outcome
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.
15 secondary outcomes
Incidence of death
Time frame: 36 completed weeks post menstrual age
Incidence of major morbidity
Time frame: 36 completed weeks post menstrual age
Incidence of death or major disability
Time frame: Up to 3 years corrected age
Incidence of 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Mordi, MD principal investigator
University of Sydney
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deferred cord clamping in people with Preterm Birth, run by University of Sydney at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Australia, New Zealand, United States, United Kingdom, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death and/or major morbidity at 36 weeks post menstrual age (time frame: 36 weeks post menstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.