- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03808051
Aeration, Breathing, Clamping Study 3 (ABC3)
Physiological-based Cord Clamping in Very Preterm Infants: a Multicentre Randomised Controlled Trial.
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for stabilisation or resuscitation were generally clamped immediately and excluded from trials, while these infants might benefit the most of DCC.
Studies in preterm lambs demonstrated that delaying cord clamping beyond ventilation onset resulted in more stable hemodynamic transition. This approach was called 'physiological-based cord clamping' (PBCC). The hypothesis of this study is that PBCC in preterm infants at birth will lead to an increase in intact survival when compared to standard care.
This study is a multicentre randomised controlled, parallel design, superiority trial, including preterm infants less than 30 weeks of gestation. The intervention is PBCC: stabilisation of the infant with the umbilical cord intact and only clamp the cord when the infant is stable. Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%. In the control group cord clamping will be performed time-based: infants are clamped first (at 30-60 seconds if the clinical condition allows) and then moved to the resuscitation table for further stabilisation.
The primary outcome will be intact survival at NICU discharge, defined as survival without cerebral injury (intraventricular haemorrhage ≥ grade 2 and/or periventricular leukomalacia ≥ grade 2 and/or periventricular venous infarction) and/or necrotizing enterocolitis (Bell stage ≥ 2).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arjan B Te Pas, Prof
- Phone Number: +31 71 5262909
- Email: a.b.te_pas@lumc.nl
Study Contact Backup
- Name: Ronny Knol, MD
- Phone Number: +31 10 703 60 77
- Email: r.knol@erasmusmc.nl
Study Locations
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-
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Amsterdam, Netherlands
- Amsterdam University Medical Centre, location AMC
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Amsterdam, Netherlands
- Amsterdam University Medical Centre, location VU
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Groningen, Netherlands
- University Medical Centre Groningen
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Leiden, Netherlands
- Leiden University Medical Centre
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Maastricht, Netherlands
- Maastricht University Medical Centre
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Nijmegen, Netherlands
- Radboud university medical centre
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Rotterdam, Netherlands
- Erasmus Medical Centre - Sophia Children's Hospital
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Utrecht, Netherlands
- University Medical Centre Utrecht
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Veldhoven, Netherlands
- Maxima Medical Centre
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Zwolle, Netherlands
- Isala Clinics Zwolle
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Infants born at a gestational age below 30 weeks in a participating centre.
- Parental consent (see 9.2).
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Significant congenital malformations influencing cardiopulmonary transition.
- Signs of acute placental abruption.
- Anterior placenta praevia or invasive placentation (accreta/percreta).
- Birth by emergency caesarean section (ordered to be executed within 15 minutes).
- Maternal general anaesthesia during caesarean section.
- Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia Polycythemia Syndrome not treated with fetoscopic laser treatment.
- Multiple pregnancy > 2 (triplets or higher order).
- Decision documented to give palliative neonatal care.
In case of twin delivery by caesarean section it is not possible to perform PBCC in both infants. Both infants will be included: the first infant will receive standard treatment and the second infant will be randomised to either PBCC or standard treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiological-based cord clamping
Stabilisation of the infant is performed while the cord is intact and the cord will be clamped after the infant is cardiopulmonary stable.
Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%.
The maximum cord clamping time is 10 minutes and prior to cord clamping a trial of weaning from PPV to CPAP is performed.
With the exception that the infant is stabilised close to the mother and the cord is clamped later, the infant will receive standard resuscitation interventions.
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See Arm description.
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Active Comparator: Time-based cord clamping
Infants are clamped first and then moved to the standard resuscitation table for further treatment and intervention needed for cardiopulmonary stabilisation.
Clamping is time based and performed immediately or delayed at 30-60 seconds, depending on the clinical condition of the infant.
Uterotonic drugs are administered immediately after cord clamping.
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See Arm description.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intact survival at NICU discharge
Time Frame: From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
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Intact survival is defined as survival without major cerebral injury (IVH ≥ grade 2 and/or PVL ≥ grade 2 and/or periventricular venous infarction) and/or NEC ≥ Bell stage 2.
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From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of treatment failure
Time Frame: From birth until one hour of age.
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Treatment failure defined as the number of participants in which abortion of prescribed procedure (intervention or control) occurred and the reasons for abortion.
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From birth until one hour of age.
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Short-term neonatal outcomes
Time Frame: From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
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Incidence of prematurity related morbidities during hospital stay.
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From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
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Short-term maternal outcomes
Time Frame: From date of randomization until five days after intervention.
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Incidence of postpartum haemorrhage (> 1000 ml) and surgical site infection after caesarean section.
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From date of randomization until five days after intervention.
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Neurodevelopmental outcome (Cognitive) at 2 years corrected age
Time Frame: Assesment at two years corrected age.
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Neurodevelopmental outcome assessed at 2 years corrected age by the standardized Bayley Scales of Infant Development III (BSID-III-NL), resulting in the Mental Developmental Index.
A score of less than 85 (1 SD below the mean of 100) is considered as delayed development.
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Assesment at two years corrected age.
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Neurodevelopmental outcome (Motor) at 2 years corrected age
Time Frame: Assesment at two years corrected age.
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Neurodevelopmental outcome assessed at 2 years corrected age by the standardized Bayley Scales of Infant Development III (BSID-III-NL), resulting in the Performance Developmental Index.
A score of less than 85 (1 SD below the mean of 100) is considered as delayed development.
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Assesment at two years corrected age.
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Functional outcome at 2 years corrected age
Time Frame: Assesment at two years corrected age.
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The proportion of participants with cerebral palsy, the proportion of participants with hearing loss requiring hearing aids and the proportion of participants with blindness.
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Assesment at two years corrected age.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental perception and appreciation of stabilisation at birth
Time Frame: Sent within 1 week after birth.
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Questionnaire sent to parents concerning the perception and appreciation of the approach during birth and the perinatal stabilisation of the infant.
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Sent within 1 week after birth.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Arjan B Te Pas, Prof, Leiden University Medical Centre
- Principal Investigator: Ronny Knol, MD, Erasmus Medical Centre Rotterdam
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL67770.058.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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